# K962014: 3I Single Use, Disposable Drills,Taps,Burs, Etc.

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Oct 18, 1996 after 148 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). 1 ancestor in all.
493 later devices descend from it; 2 cite it directly.
0 of 495 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.
- (no number) Nobelpharma, “Branemark System Drills and Screw Taps”: named in the summary without a submission number
- (no number) Brasseler, Inc. Surgical Instruments: named in the summary without a submission number
- (no number) The Anspach Effort, Inc. High Speed Drills and cutting tips for Right and Contra Angle cutter applications: named in the summary without a submission number

## Most influential descendants
- K022113: 3I Dental Implant Accessories (2002), 463 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
- K051189: Prevail Dental Implants (2005), 317 descendants of its own
- K051461: 3I Osseotite Dental Implants (2005), 312 descendants of its own

Source page: https://510kreport.com/device/K962014
Methodology: https://510kreport.com/methodology
