# K222211: Implant Direct Dental Implant Systems Portfolio - MR Conditional

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Feb 2, 2023 after 192 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Simply Implants (previously cleared per K201553) Simply dental implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization. Short (6mm) 3.7mmD implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization. Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture- mounts (previously cleared per K192221) Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization. Short (<10mm) 3.7mm implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization. The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy2, Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment. As an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients. Fixture-mounts as an abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Fixture-mounts as an abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors. Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 implants are compatible with the following abutments. Manufacturer Abutment Line Platform Diameter Implant Direct Legacy 3.0mm, 3.5mm, 4.5mm, 5.7mm Custom Legacy and Custom InterActive Titanium Abutments (previously cleared per K192218) Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients. Custom Titanium Abutment for narrow (3.2mmD, 3.3mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements. Custom Titanium Abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors. Custom Legacy Titanium Abutments are compatible at the implant-level with Legacy1, Legacy2, Legacy3, Legacy4, simplyLegacy2 and simplyLegacy3 implants, excluding 6mm length implants. Implant Line Body Diameter Platform Diameter Implant Length Legacy1 3.7mm, 4.2mm, 4.7mm, 5.7mm 3.5mm, 4.5mm, 5.7mm 8mm to 16mm Legacy2, Legacy3, Legacy4, 3.2mm, 3.7mm, 4.2mm, 3.0mm, 3.5mm, simplyLegacy2, simplyLegacy3 4.7mm, 5.2mm, 5.7mm, 7.0mm 4.5mm, 5.7mm Custom InterActive Titanium Abutments are compatible at the implant-level with InterActive, SimplyInterActive and SwishActive implants, excluding 6mm length implants. Implant Line Body Diameter Platform Diameter Implant Length InterActive, simplyInterActive 3.2mm, 3.7mm, 4.3mm, 5.0mm 3.0mm, 3.4mm 8mm to16mm SwishActive 3.3mm, 4.1mm, 4.8mm 3.0mm, 3.4mm 8mm to16mm LegacyTM SMARTBase Abutments (previously cleared per K191458) implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations. The Legacy SMARTBase Abutment system integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners and lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Legacy SMARTBase system consist of two major parts: the titanium base and zirconia top components make up a two-piece abutment. Legacy SMARTBase abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Legacy SMARTBase abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors. Compatibility Legacy SMARTBase engaging abutments are compatible at the implant level with Legacy (3.0mm, 3.5mm, 4.5mm and 5.7mm platform diameter) implants, excluding 6mm length implants. Implant Line Body Diameter Platform Diameter Implant Length Legacy1 3.7mm, 4.2mm, 4.7mm, 5.7mm 3.5mm, 4.5mm, 8mm, 10mm, 5.7mm 11.5mm, 13mm, Legacy2, 3, 4, simplyLegacy2, 3.2mm, 3.7mm, 4.2mm, 4.7mm, 3.0mm, 3.5mm, 16mm simplyLegacy3 5.2mm, 5.7mm, 7.0mm 4.5mm, 5.7mm InterActive SMARTBase Abutments (previously cleared per K181359) InterActive/SwishActive Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate SMARTBase support for fixed bridgework. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization. Compatibility: InterActive SMARTBase abutments are compatible at the implant level with InterActive (3.0mm and 3.4mm Platform) and SwishActive (3.0mm and 3.4mm Platform) system implants. Manufacturer Implant Body Diameter Implant Platform Implant Direct InterActive 3.2mm, 3.7mm, 4.3mm, 5.0mm 3.0mm, 3.4mm Implant Direct SwishActive 3.3mm, 4.1mm, 4.8mm 3.0mm, 3.4mm Custom Bars (previously cleared per K162633) Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. Custom bars are compatible at the implant level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) System implants. Manufacturer Implant Line Body Diameter Implant Platform Implant Direct InterActive 4.3mm, 5.0mm 3.4mm Implant Direct SwishActive 4.8mm 3.4mm Custom bars are compatible at the abutment level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) system straight multi-unit abutments. Manufacturer Implant Line Implant Platform Implant Direct InterActive 3.4mm Implant Direct SwishActive 3.4mm GPS® Angled Abutments (previously cleared per K153509) GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Compatibility: Legacy System: Prosthetically compatible with Zimmer Dental Tapered Screw-Vent system 3.5mm platform implants (3.7mmD, 4.1mmD, 8mm-16mm Length), 4.5mm platform implants (4.7mmD, 8mm-16mm Length), and 5.7mm platform implants (6.0mmD, 8mm-16mm Length). SwishTapered System: Prosthetically compatible with Straumann Standard and Standard Plus system RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length) and WN platform implants (4.8mmD, 6mm-12mm Length). SwishPlus System: Prosthetically compatible with Straumann Standard and Standard Plus system RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length) and WN platform implants (4.8mmD, 6mm-12mm Length). SwishActive Implants: SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActiveTM NP (Narrow Platform 3.0mm diameter) and NobelActiveTM RP (Regular Platform- 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive TM NP (Narrow Platform 3.0mm diameter) and NobelActive TM RP (Regular Platform 3.4mm diameter) titanium abutments. InterActive 3.0 and 3,4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive TM NP (Narrow Platform 3.0mm diameter) and NobelActive TM RP (Regular Platform 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants. InterActive System: InterActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActiveTM NP (Narrow Platform 3.0mm diameter) and NobelActiveTM RP (Regular Platform 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActiveTM NP (Narrow Platform 3.0mm diameter) and NobelActiveTM RP (Regular Platform 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants. InterActive/SwishActive Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. These implants are also indicated for multiple tooth replacements or denture stabilization. Compatibility: InterActive and SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Bio 3.0mm diameter) and 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection N 3.0mm diameter) 3.4mm diameter) (3.5-5.0mmD, 8.5- 18mmLength) implants. Legacy3 6mm Length Implants (previously cleared per K131097) Legacy3 6mm Length consists of two-piece implants for one-stage or two-stage surgical procedures. There implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. InterActive/SwishPlus2 Implant System (previously cleared per K130572) lnterActive/SwishPlus2 Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple -unit restorations and terminal or intermediate abutment support for fixed bridgework: Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Narrow Diameter.(3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization. Compatibility: lnterActive and SwishPlus2 implants are prosthetically compatible with lnterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connec - 3.0mm diameter) and (Regular Platform - 3.4mm diameter) abutments. lnterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection. (Narrow Platform- RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants. Spectra-System Dental Implants 2008 (previously cleared per K090234) Spectra-System Dental Implants 2008 are comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single-tooth or multiple-tooth restorations, recognizing bone stability and appropriate occlusal load requirements. Swiss Dental Implant System (previously cleared per K081396) The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function. Spectra-System Abutments 2008 (previously cleared per K081101) Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandible or maxilla. Prostheses can be screw or cement retained to the abutment. ReActive Dental Implant System (previously cleared per K080713) The ReActive Dental Implant System are dental implant fixtures that are a part of a two-piece implant system. The ReActive implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements. ScrewIndirect Narrow Dental Implants (previously cleared per K080633) Screwlndirect Narrow Dental Implants are implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for immediate loading for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met. RePlus Dental Implants With HA Coating (previously cleared per K073161) The RePlus Dental Implants with HA coating are dental implant fixtures that are a part of a two-piece implant system. The RePlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate loading for support of single tooth and/or multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met. ScrewPlus Dental Implants With HA Coating (previously cleared per K073049) The ScrewPlus Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system that is to be used for single-stage or two-stage surgical procedures. The ScrewPlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements. Legacy Dental Implants With HA Coating (previously cleared per K073033) The Legacy Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system. The Legacy implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements. Spectra Dental Implant System (previously cleared per K061319) The Spectra Dental Implant System consists of one-piece or two-piece implants for single-stage or two-stage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established. The ScrewDirect 3.0mm implant is indicated for: 1. An artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. 2. Multiple tooth replacements or denture stabilization. The Screw Redirect implant is intended for support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of the partially edentulous maxillary jaw. It is indicated for immediate functional loading when four or more implants are splinted together in the endentulous upper or lower jaw. The Screw Indirect implant is indicated for the support and retention of bar overdentures or as a terminal or intermediary attachment for screw-retained fixed bridgework. It is indicated for immediate functional loading when four or more implants are splinted together in the edentulous upper or lower jaw. This implant model is not indicated for use with abutments, only with a 2mm extender. Legacy Abutment System (previously cleared per K060063) The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients. The Legacy Abutment System is compatible with implants that have mating diameters, lead-in bevels, internal hex sizes, and 1-72UNF internal threads, as shown in the Zimmer Dental Tapered Screw-Vent Surgical Manual. Implant Direct LLC will monitor the compatible implants for modifications to ensure future compatibility. In the event of any modification, Implant Direct LLC will either modify the Legacy abutment to ensure compatibility, or cease claiming compatibility to the modified Zimmer Dental Screw-Vent implants.

Source page: https://510kreport.com/device/K222211
Methodology: https://510kreport.com/methodology