Ultrasonic Scaler Insert DF10/25K

• FDA 510(k) K011179 decided 5 Jun 2001 Active
• FDA GUDID UDI-DI 07290016281118 listed 24 Sep 2016 Listed

1. 5 Jun 2001 Cleared FDA 510(k) K011179
2. 24 Sep 2016 Listed FDA GUDID 07290016281118

Trade name

Ultrasonic Scaler Insert

Generic name

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Model / Ref / Catalog

DF10/25K, 508601

Primary DI / UDI-DI

07290016281118

510(k) Number

K011179 ↗

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

Category: Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Other devices filed under FDA product code ELC (Scaler, Ultrasonic).

• SUPRASSON P MAX by Satelec
• EVOCLEAN CLEANsert Ultrasonic Insert by TTBIO CORP.
• SONUS III by Litton Dental Products
• SATELEC SUPRASSON PIEZOMATIC P2 by Spelna, Inc.
• MINIPIEZON by Electro Medical Systems (Ems Sa)
• ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 by Dentsply Intl.
• STERI-MATE STERILIZABLE HANDPIECE by Dentsply International
• Varios Combi Pro2 by NAKANISHI INC.
• DELSONIC 2000 by Sds Dental, Inc.
• Sonendo GentleWave System by SONENDO, INC.

• Ultrasonic Scaler Insert DF100/30K R

  Class II

  FDA 510(k) K011179 Active Cleared 5 Jun 2001 GUDID on market

• Jetpolisher 2000 Midwest 1.1

  Class II

  FDA 510(k) K014249 Active Cleared 19 Feb 2002 GUDID on market

• Ultrasonic Scaler Insert DP100/25K L

  Class II

  FDA 510(k) K011179 Active Cleared 5 Jun 2001 GUDID on market

• Ultrasonic Scaler Insert DF1000/30K

  Class II

  FDA 510(k) K011179 Active Cleared 5 Jun 2001 GUDID on market

See all devices from Deldent Ltd. →