enCore Impression Material
FDA 510(k) clearance K251926 · decided 2026-03-17
Clearance details
- K-number
- K251926
- Device name
- enCore Impression Material
- Applicant
- Encore Guards
- Decision
- Substantially Equivalent
- Date received
- 2025-06-23
- Decision date
- 2026-03-17
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- SHI
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Encore Guards
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Remi Impression Material (K251724) | Grindguard, Inc. | 2026-02-25 |
Recalls involving this device
No recalls on record reference this clearance.