510(k) clearance
ClearClub Impression Material
- 510(k) number
- K261888
- Applicant
- ClearClub
- Decision date
- Sep 16, 2026
- Date received
- Jun 5, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- SHI
- Device type
- Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
- Device class
- Class II
- Regulation
- 21 CFR 872.3660
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Inglewood, CA, US