Deldent 508801
Deldent 508801 is a Class II device made by Young Innovations, Inc., cleared under FDA 510(k) K011179 on 5 Jun 2001 and listed in FDA GUDID since 24 Nov 2022 (UDI-DI 00816577021597), 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 | Number00816577021597 | Date24 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011179 | Date5 Jun 2001 | StatusActive |
Official records
- AccessGUDID record 00816577021597
- FDA 510(k) database K011179
Across registries
- FDA 510(k) K011179 decided 5 Jun 2001 Active
- FDA GUDID UDI-DI 00816577021597 listed 24 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K011179
- Listed FDA GUDID 00816577021597
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Deldent
- Generic name
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic
- Model / Ref / Catalog
- 508801
- Primary DI / UDI-DI
- 00816577021597
- 510(k) Number
- FDA product code
- ELC
- GMDN term
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic
- Device class
- Class II
- Regulation number
- 872.4850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization