# K891615: Surgical Drills

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations International, Inc.
- Decided: Apr 17, 1989 after 28 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.
495 later devices descend from it; 2 cite it directly.
0 of 496 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962014: 3I Single Use, Disposable Drills,Taps,Burs, Etc. (1996), 493 descendants of its own
- 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

Source page: https://510kreport.com/device/K891615
Methodology: https://510kreport.com/methodology