Air-Flow
by E.M.S. Electro Medical Systems S.A. 64 variants
Air-Flow (EL-541A/HF) is a dental abrasive air jet system handpiece (FDA Class I; FDA product code EFB, Handpiece, Air-Powered, Dental) made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K132478 on 11 Apr 2014 and listed in FDA GUDID since 1 Sep 2018 (UDI-DI 07613353046729), 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 | GUDID listing | Number07613353046729 | Date1 Sep 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132478 | Date11 Apr 2014 | StatusActive |
Official records
- AccessGUDID record 07613353046729
- FDA 510(k) database K132478
Across registries
- FDA 510(k) K132478 decided 11 Apr 2014 Active
- FDA GUDID UDI-DI 07613353046729 listed 1 Sep 2018 Listed
Timeline
- Cleared FDA 510(k) K132478
- Listed FDA GUDID 07613353046729
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dental abrasive air jet system handpiece
- Model / Ref / Catalog
- a, EL-541A/HF
- Primary DI / UDI-DI
- 07613353046729
- 510(k) Number
- FDA product code
- EFB
- GMDN term
- Dental abrasive air jet system handpiece
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
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