# K964944: Round Dental Bur

- Pathway: 510(k) (Traditional)
- Applicant: Steri-Oss, Inc.
- Decided: Feb 10, 1997 after 62 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) Brasseler Corporation’s Round Dental Burs: named in the summary without a submission number

## Indications for use
The intended use is to cut hard structures in the mouth, such as teeth or bone. One such application is to cut holes in cortical plate bone preparatory to creation of an osteotomy for placement of dental implants.

Source page: https://510kreport.com/device/K964944
Methodology: https://510kreport.com/methodology