Statis Dental Handpieces
by Scican Ltd
510(k) K071891
Statis Dental Handpieces is a medical device (FDA Class I; FDA product code EFB, Handpiece, Air-Powered, Dental) made by Scican Ltd, cleared under FDA 510(k) K071891 on 13 Sep 2007, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071891 | Date13 Sep 2007 | StatusActive |
Official records
- FDA 510(k) database K071891
Recalls
-
- Ongoing Z-1208-2023
Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
Timeline
- Cleared FDA 510(k) K071891
- Recall initiated FDA recalls Z-1208-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EFB
- FDA applicant
- Scican , Ltd.
- Device class
- Class I
- Regulation
- 21 CFR Part 872.4200
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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