510(k) · Cleared
ClearedMRI Compatibility for Existing Zimmer Dental Implant Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Dental, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on May 17, 2017 after a 460-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 17, 2017
- Review
- 460 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
Tapered Screw-Vent Zimmer Dental Implant Zimmer dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Zimmer One-Piece (ZOP) Dental Implant Zimmer One-Piece Implants are indicated for the support and…
Read the full statement (2,180 words)
Tapered Screw-Vent Zimmer Dental Implant
Zimmer dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Zimmer One-Piece (ZOP) Dental Implant
Zimmer One-Piece Implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor, and maxillary lateral incisor regions of partially edentulous jaws. The Zimmer One-Piece Implant must be splinted if two or more are used adjacent to each other. The Zimmer One-Piece Implant may be immediately restored with a temporary prosthesis that is not in functional occlusion
Screw-Vent Zimmer Dental Implant
Zimmer Dental implant systems are designed for use in endentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
Advent Zimmer Dental Implant
Zimmer dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
SwissPlus Dental Implant
Zimmer Dental implant systems are designed for use in endentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
Spline Twist Dental Implant
Zimmer Dental implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
Trabecular Metal Implant™ (Tapered Screw Vent® X Implant System)
Zimmer Dental implant systems are (Tapered Screw Vent® X Implant System) designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The 3.7mmD Trabecular Metal Implants should be splinted to additional implants when used in the pre- molar region and should not be used in the molar region.
The 4.1mmD Trabecular Metal Implants should be splinted to additional implants when used in the molar region.
Zimmer 3.1mmD Dental Implants
The 3.1mmD Eztetic Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The 3.1mmD Eztetic Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical).
The 3.1mmD Eztetic Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated & Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated
Zimmer dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Zimmer Dental Tapered Screw-Vent® T Implant & Zimmer Dental Tapered Screw-Vent® M Implant
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Zimmer Contour Hex-Lock Abutment, Straight
Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single or multiple-unit restoration.
Zimmer Contour Hex-Lock Abutment, 17°
Abutment is used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single or multiple-unit restoration.
Zimmer Dental Inc. Hex-Lock Abutment
Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single or multiple-unit restoration.
Hex-Lock Short Abutments
Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single or multiple-unit restoration.
Zimmer Dental Inc. 20° Angled Abutment
Zimmer Dental Implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
“Cast-To” Gold Abutments, Engaging
Zimmer Dental Implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Zimmer Cast-To Gold Abutment for the 3.1mmD Dental Implant System, Engaging
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging is intended for use in the creation of a customized abutment for a cement-retained crown or bridge, or a customized screw-retained restoration.
“Cast-To” Gold Abutments, Non-Engaging
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Zimmer Cast-To Gold Abutment for the 3.1mmD Dental Implant System, Non-Engaging
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Non-Engaging, is intended for use in the creation of customized multiple-unit restorations on implants (e.g., bars and bridges), when anti-rotation of the abutment is not necessary.
2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex
The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.
The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single- or multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration.
The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cement-retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations.
Angled Tapered Abutments, 15°
The Angled Tapered Abutment is used for a terminal or intermediate abutment for screw-retained multiple-unit restorations. The 30º Angled Tapered Abutment must be used within 45º of parallelism for a splinted restoration.
Angled Tapered Abutments, 30°
The Angled Tapered Abutment is used for a terminal or intermediate abutment for screw-retained multiple-unit restorations. The 30° Angled Tapered Abutment must be used within 45°of parallelism for a splinted restoration. The 15° Angled Tapered Abutment must be used within 30° of parallelism for a splinted restoration.
Zimmer Dental Inc. Screw Vent Ball Abutment
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Spline Temporary Abutment
Temporary Abutment, Engaging: Spline engaging titanium alloy cylinder with retentive parallel walls and a flared cuff. Attaches to the Spline Implant with a separate screw. For use when a temporary prosthesis for up to six weeks is desired. Single or multiple units. Do not use as a permanent abutment. Not to exceed six weeks of placement.
Temporary Abutment, Non-Engaging: Adjustable titanium alloy cylinder with retentive parallel walls and a cuff. Attaches to the Spline Implant with a separate screw. Does not engage the tines. For use when a temporary prosthesis for up to six weeks is desired. Single or multiple units.
Spline Fixed Abutment
For use as a terminal or intermediate abutment for cemented prosthesis. Abutments must be parallel to within 7.5° for Spline Implant or be prepped to be parallel. The Spline Abutments can be used for a single tooth or splinted to other abutments. Single use.
Spline Fixed Abutment, 17°
For use as a terminal or intermediate abutment for cemented prosthetics when long axis of abutment needs to be changed by 15°, 17° or 25°. Abutment can be used for single tooth or splinted restorations. Single use.
Zimmer Zfx Titanium Abutment for NobelActive Implant System
The Zimmer Zfx Titanium Abutment for NobelActive Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelActive and NobelReplace Conical Connection implants with a Narrow Platform (NP) Ø 3.5mm, or Regular Platform (RP) Ø 3.9mm.
Zimmer Zfx Abutment for NobelReplace Implant System
The Zimmer Zfx Abutment for NobelReplace Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelReplace, Replace Select and NobelSpeedyReplace implants with a Narrow Platform (NP) Ø3.5 mm, Regular Platform (RP) Ø 4.3 mm, WidePlatform (WP) Ø 5.0 mm or 6.0 Platform (6.0) Ø 6.0mm.
Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System
The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Straumann Bone Level implants with a Narrow CrossFit Platform Connection (NC) Ø 3.3mm or Regular CrossFit Platform Connection (RC) Ø 4.1mm or 4.8mm.
Zimmer Zfx Titanium Base Abutment for Tapered Screw Vent Implant System
The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and Zimmer Zfx Abutment Coping or Crown as part of a straight or angled two piece abutment. The combination of the titanium base stock abutment and the abutment coping is designed for use as a terminal or intermediate abutment for cement or screw retained prostheses. The two-piece abutment is used for a single -unit or multi-unit(bridge) restoration. The Zimmer Zfx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility.
Zimmer Zfx Abutment for Biomet 3i Certain Implant System
Titanium Abutment for Biomet 3i Certain Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Biomet 3i internal connection implants with a 3.4mm, 4.1mm, 5.0mm, or 6.0mm Platform.
Zimmer® Patient Specific Abutment, Internal Hex, Titanium
The Zimmer Patient Specific Abutment, Internal Hex, Titanium is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration.
Tapered Screw-Vent Healing Collar
The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.
2.9mm Healing Collar
The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.
Zimmer Dental Surgical Cover Screw
The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing. The Healing Screw and Surgical Cover Screw are for single use only.
2.9mm Healing Screw
The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing. The Healing Screw is for single use only.
Retaining Screw
The Retaining Screws are intended to be used for securing the temporary abutments, final abutments, and impression transfers to the implant or implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K160398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160398: MRI Compatibility for Existing Zimmer Dental Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160398
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026