# K030614: 3I Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Sep 15, 2003 after 201 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
Longest line of descent: 4 generations back to K925765 (1993). 55 ancestors in all.
319 later devices descend from it; 3 cite it directly.
0 of 375 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860653: Pure Titanium Screw-Type for Dental Implant, Otc/America (1986) Summary page 1.
- K874590: Innovative Implants and Cover Screws, Implant Innovations International, Inc. (1988) Summary page 1.
- K935544: 3I Standard Threaded/Self-Tapping Threaded Implants Modification, Implant Innovations International, Inc. (1995) Summary page 1.
- K950204: 3I Standard Threaded/Self-Tapping Threaded Implants, Miniplants (TM), Implant Innovations, Inc. (1995) Summary page 1.
- K955428: 3I Hydroxylapatite Coated Standard Threaded & Self-Tapping Implants, Implant Innovations, Inc. (1996) Summary page 1.
- K972444: 3I Innovative Implants and Cover Screws, Implant Innovations, Inc. (1997) Summary page 1.
- K983347: Osseotite Dental Implants, Implant Innovations, Inc. (1999) Summary page 1.
- K014235: Osseotite NT Dental Implants & Accessories, Implant Innovations, Inc. (2002)
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants, Implant Innovations, Inc. (2002) Summary page 1.
- K871863: Adbutment Cylinder and Screw, Implant Innovations International, Inc. (1987) Summary page 1.
- K871954: Abutment Head Post, Implant Innovations International, Inc. (1987) Summary page 1.
- K891613: Overdenture Attachment, Implant Innovations International, Inc. (1989) Summary page 1.
- K895462: Osseodent Dental Attachments, Collagen Corp. (1990) Summary page 1.
- K895463: Osseodent (R) Precision Dental Attachments, Collagen Corp. (1990) Summary page 1.
- K904228: Osseodent Dental Attachments (Non-Angled), Collagen Corp. (1990) Summary page 1.
- K934126: One and Two Piece Temporary Healing,(Emergence Profile) Abutments, Implant Innovations, Inc. (1994) Summary page 1.
- K933969: Tapered Abutment and Related Components, Implant Innovations, Inc. (1994) Summary page 1.
- K933462: Conical Abutment, Implant Innovations, Inc. (1994) Summary page 1.
- K932123: Implant Innovation Pre-Angled Abutment System, Implant Innovations International, Inc. (1994) Summary page 1.
- K951553: 3I Asyst Abutment Package System, Implant Innovations, Inc. (1995) Summary page 1.
- K022113: 3I Dental Implant Accessories, Implant Innovations, Inc. (2002)
- K992937: Dental Implant, Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 1.
- K994376: Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA, Friadent GmbH (2000) Summary page 1.
- K984104: Iti Dental Implant System, Straumann USA (1999) Summary page 1.
- K980620: Dentatus Mti  Modular Transitional Implants and Prosthetic System, Dentatus USA, Ltd. (1998) Summary page 1.

## Most influential descendants
- K041402: Modification to Osseotite NT Certain Implants (2004), 318 descendants of its own
- K051189: Prevail Dental Implants (2005), 317 descendants of its own
- K051461: 3I Osseotite Dental Implants (2005), 312 descendants of its own
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite (2007), 211 descendants of its own
- K063341: 3I Osseotite Certain Dental Implants (2007), 209 descendants of its own

## Indications for use
3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures. In addition, when a minimum of 4 implants, 2 10 mm in length, are placed in the the mandible and splinted in the anterior region, immediate loading is indicated.

Source page: https://510kreport.com/device/K030614
Methodology: https://510kreport.com/methodology