Ultrapro TX Cordless 5534-
Ultrapro TX Cordless 5534- is a Class I device made by Ultradent Products, Inc., cleared under FDA 510(k) K211531 on 17 Dec 2021 and listed in FDA GUDID since 27 May 2023 (UDI-DI 00883205035424), 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 | Number00883205035424 | Date27 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211531 | Date17 Dec 2021 | StatusActive |
Official records
- AccessGUDID record 00883205035424
- FDA 510(k) database K211531
Across registries
- FDA 510(k) K211531 decided 17 Dec 2021 Active
- FDA GUDID UDI-DI 00883205035424 listed 27 May 2023 Listed
Timeline
- Cleared FDA 510(k) K211531
- Listed FDA GUDID 00883205035424
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ultrapro TX Cordless
- Generic name
- Dental surgical power tool motor, electric
- Model / Ref / Catalog
- 5534-
- Primary DI / UDI-DI
- 00883205035424
- 510(k) Number
- FDA product code
- EKX
- GMDN term
- Dental surgical power tool motor, electric
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
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