Instruments A P PS FS-458
by E.M.S. Electro Medical Systems S.A.
Instruments A P PS FS-458 is a Class II device made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K253254 on 28 Jan 2026 and listed in FDA GUDID since 16 Feb 2026 (UDI-DI 07613353180089), active as of 23 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 | Number07613353180089 | Date16 Feb 2026 | StatusListed |
| United States | FDA 510(k) | NumberK253254 | Date28 Jan 2026 | StatusActive |
Official records
- AccessGUDID record 07613353180089
- FDA 510(k) database K253254
Across registries
- FDA 510(k) K253254 decided 28 Jan 2026 Active
- FDA GUDID UDI-DI 07613353180089 listed 16 Feb 2026 Listed
Timeline
- Cleared FDA 510(k) K253254
- Listed FDA GUDID 07613353180089
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Instruments A P PS
- Generic name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal
- Model / reference
- FS-458
- Primary DI / UDI-DI
- 07613353180089
- 510(k) Number
- FDA product code
- ELC
- GMDN term
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal
- Device class
- Class II
- Regulation number
- 872.4850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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