Product code SHI
- Device name
- Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3660
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K251926 | enCore Impression Material | Encore Guards | 2026-03-17 |
| K251724 | Remi Impression Material | Grindguard, Inc. | 2026-02-25 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00860013500726 | Remi Impression Kit | GrindGuard Inc. | 2026-03-02 |