510(k) K261888
K261888 is an FDA 510(k) premarket notification submitted by ClearClub for the device "ClearClub Impression Material". The FDA issued a decision of Substantially Equivalent on September 16, 2026. The device falls under product code SHI (Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter), a Class II device regulated under 21 CFR 872.3660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2026
- Date Received
- June 5, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type
An over-the-counter device that is intended to reproduce the structure of a patient's teeth and gums for the fabrication of patient-matched mouthguards/nightguards.