# K080687: Smartburs

- Pathway: 510(k) (Traditional)
- Applicant: S.S. White Burs, Inc.
- Decided: Jun 20, 2008 after 101 days
- Product code: EJL (Bur, Dental)
- Device class: 1
- Regulation: 21 CFR 872.3240
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
After primary access using another instrument, Smartburs is intended to selectively remove decayed dentin, without removal of healthy dentin from tooth surfaces. Smartburs is not designed to cut or remove enamel, composite, amalgam, cementum, or healthy dentin.

Source page: https://510kreport.com/device/K080687
Methodology: https://510kreport.com/methodology