Ultrasonic Scaler Insert DF10/30K
by Deldent Ltd.
Ultrasonic Scaler Insert DF10/30K (508701) is a Class II device made by Deldent Ltd., cleared under FDA 510(k) K011179 on 5 Jun 2001 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07290016281217), 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 | Number07290016281217 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011179 | Date5 Jun 2001 | StatusActive |
Official records
- AccessGUDID record 07290016281217
- FDA 510(k) database K011179
Across registries
- FDA 510(k) K011179 decided 5 Jun 2001 Active
- FDA GUDID UDI-DI 07290016281217 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K011179
- Listed FDA GUDID 07290016281217
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ultrasonic Scaler Insert
- Generic name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal
- Model / Ref / Catalog
- DF10/30K, 508701
- Primary DI / UDI-DI
- 07290016281217
- 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
Similar devices
Other devices filed under FDA product code ELC (Scaler, Ultrasonic).
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- SIROSON L AND SIROSONIC L ULTRASONIC SCALERS by SIRONA Dental Systems GmbH
- Piezomed SA-435 M Module plus 30406000 by W&H Dentalwerk Burmoos
- DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER by American Green Dent. Mfg, Inc.
- Ultrasonic Scaler, Models UDS-N1, UDS-N2, UDS-J, UDS-K, UDS-L by Guilin Woodpecker Medical Instrument Co., Ltd.
- A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM by A-Dec, Inc.
- PERIODONTAL DEBRIDING SOLUTION E by Dentsply Intl.
- Ultrasonic scaler by Nanning VV Dental Co., Ltd.
- MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT by HU-FRIEDY MFG CO., LLC