Y-Mic
510(k) K161639
Y-Mic is a medical device (FDA Class II; FDA product code ELC, Scaler, Ultrasonic) made by Micron Corporation, cleared under FDA 510(k) K161639 on 22 Dec 2016, 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 | NumberK161639 | Date22 Dec 2016 | StatusActive |
Official records
- FDA 510(k) database K161639
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4850
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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