# K973771: Dental/Surgical Drills, Burs, Taps

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Dec 4, 1997 after 63 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.
No later device cites it as a predicate yet.
0 of 1 device 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) 3i drills, taps and burs with a polished coating: named in the summary without a submission number
- (no number) 3i drills, taps and burs with a titanium nitride (TiN) coating: named in the summary without a submission number

## Indications for use
Surgical drills, taps and burs are used in dental, oral/maxillofacial surgery for preparing the bone (osteotomy), to receive an implant(s) or other device for bone fracture repair for restorative reconstruction. Trephine burs are used harvest bone material for autologous bone grafting procedures and to remove fractured surgical and implantable devices from the bone.

Source page: https://510kreport.com/device/K973771
Methodology: https://510kreport.com/methodology