# K992334: Endosseous Implants and Abutments- Tin Coating

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Oct 8, 1999 after 87 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.
542 later devices descend from it; 4 cite it directly.
0 of 543 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Current 3i implant/abutments: named in the summary without a submission number
- (no number) Competitive systems using TiN coatings: named in the summary without a submission number

## Most influential descendants
- K022113: 3I Dental Implant Accessories (2002), 463 descendants of its own
- K022795: Modification to the Maestro System (2002), 332 descendants of its own
- K030463: Modification to the Maestro System (2003), 331 descendants of its own
- K030614: 3I Dental Implants (2003), 319 descendants of its own
- K041402: Modification to Osseotite NT Certain Implants (2004), 318 descendants of its own

## Indications for use
Endosseous implants and abutments are indicated for surgical placement into the upper and lower jar arches-as permanent support for prosthetic appliances, to restore a patient's masticatory function. Proposed Titanium Nitride ("TiN") coating applied to implants/abutments improves the overall esthetics of the completed restoration.

Source page: https://510kreport.com/device/K992334
Methodology: https://510kreport.com/methodology