1ST Impression
510(k) K921571
1ST Impression is a medical device (FDA Class II; FDA product code ELW, Material, Impression) made by Wykle Research, Inc., cleared under FDA 510(k) K921571 on 10 Sep 1993, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921571 | Date10 Sep 1993 | StatusActive |
Official records
- FDA 510(k) database K921571
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELW
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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