# K962394: Implant Integration Systems Drills and Taps

- Pathway: 510(k) (Traditional)
- Applicant: Implant Integration Systems, Inc.
- Decided: Oct 11, 1996 after 113 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: 1 generation back to K891615 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891615: Surgical Drills, Implant Innovations International, Inc. (1989) Summary page 1.
- K902158: Titanium/Stainless Steel Dental Implant Drill Comp, Impla-Med (1990) Summary page 1.
- K915733: Steri-Oss Drills and Taps, Steri-Oss, Inc. (1992) Summary page 1.

## Indications for use
The Implant Integration Systems Surgical Drills are intended to be used in the placement of the “Dual Integrator” Dental Implant (K944225).

Source page: https://510kreport.com/device/K962394
Methodology: https://510kreport.com/methodology