510(k) K251926
- Device
- enCore Impression Material
- Applicant
- Encore Guards
- 510(k) number
- K251926
- Product code
- SHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-17
- Date received
- 2025-06-23
- Regulation
- 872.3660
- Classification name
- Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Benjamin Li
- Address
- 1520 Brookhollow Dr. Suite 38 Santa Ana CA US 92705 92705
FDA Registration Numbers#
- 3017575849
- 3020749939
Source Documents#
Other 510(k) Records For Product Code SHI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251724 | Remi Impression Material | Grindguard, Inc. | 2026-02-25 |