Remi Impression Material
FDA 510(k) clearance K251724 · decided 2026-02-25
Clearance details
- K-number
- K251724
- Device name
- Remi Impression Material
- Applicant
- Grindguard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-04
- Decision date
- 2026-02-25
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- SHI
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| enCore Impression Material (K251926) | Encore Guards | 2026-03-17 |
Recalls involving this device
No recalls on record reference this clearance.