SHI — Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter Class II
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251724 | grindguard | Remi Impression Material | February 25, 2026 |