ClearClub Impression Material— 510(k) K261888
Substantially EquivalentClearClub
FDA 510(k) clearance K261888 for ClearClub Impression Material, Substantially Equivalent on 2026-09-16. Applicant: ClearClub. Device class: 2.
Summary
ClearClub Impression Material is from ClearClub, filed under product code SHI (Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter). The record doesn't describe the material beyond its name and code.
Class II, 21 CFR 872.3660. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
ClearClub filed from Inglewood, California. The decision came 103 calendar days after FDA received it (June 5 to September 16, 2026).
Clearance details
- Applicant
- ClearClub
- Product code
- Product code SHI
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Inglewood, CA, US
Recent devices under product code SHI
view allData sourced from openFDA. This site is unofficial and independent of the FDA.