Interproximal Reduction System
510(k) K053368
Interproximal Reduction System is a medical device (FDA Class I; FDA product code EFB, Handpiece, Air-Powered, Dental) made by Dentsply International, cleared under FDA 510(k) K053368 on 29 Mar 2006, 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 | NumberK053368 | Date29 Mar 2006 | StatusActive |
Official records
- FDA 510(k) database K053368
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EFB
- Device class
- Class I
- Regulation
- 21 CFR Part 872.4200
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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