SHI — Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter Class II
FDA product code SHI covers "Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter", a Class II medical device regulated under 21 CFR 872.3660. Submissions are reviewed by the Dental panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SHI
- Device Class
- Class II
- Regulation Number
- 872.3660
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
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.