# Britesmile, Inc.

- Location (FDA's records): North Attleboro, MA
- FDA decisions: 2 (2001–2004): 2 510(k) clearances
- Product codes: EIE (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K010935: Britesmile Barrier Material (2001), cited by 1

## Recent decisions
- K040797: Britesmile Masking Cream (Apr 2, 2004)
- K010935: Britesmile Barrier Material (Sep 5, 2001)

Source page: https://510kreport.com/company/britesmile