Suresmile System
510(k) K002620
Suresmile System is a medical device (FDA Class I; FDA product code EIA, Unit, Operative Dental) made by Orametrix, Inc., cleared under FDA 510(k) K002620 on 16 Nov 2000, 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 | NumberK002620 | Date16 Nov 2000 | StatusActive |
Official records
- FDA 510(k) database K002620
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EIA
- Device class
- Class I
- Regulation
- 21 CFR Part 872.6640
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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