510(k) clearance
Daybreak Impression Material
- 510(k) number
- K262421
- Applicant
- Sleepcare, LLC
- Decision date
- Oct 20, 2026
- Date received
- Jul 16, 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
- Los Angeles, CA, US