Ultrasonic Scaler Insert DF100/30K R

• FDA 510(k) K011179 decided 5 Jun 2001 Active
• FDA GUDID UDI-DI 07290016281255 listed 24 Sep 2016 Listed

1. 5 Jun 2001 Cleared FDA 510(k) K011179
2. 24 Sep 2016 Listed FDA GUDID 07290016281255

Trade name

Ultrasonic Scaler Insert

Generic name

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Model / Ref / Catalog

DF100/30K R, 508705

Primary DI / UDI-DI

07290016281255

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).

• Varios CR-1 by NAKANISHI INC.
• Compact Piezo P2K by Mectron S.p.A.
• BIOSONIC ULTRASONIC SCALER SYSTEM by Coltene/Whaledent Inc.
• Amdent Model 830 Ultrasonic Scaler by Pathway Products, Inc.
• Ultrasonic Scaler by Nanning Baolai Medical Instrument Co., Ltd.
• EMS Surface Mount Ultrasonic Scaler by Electro Medical Systems (Ems Sa)
• TTBIO EVOCLEAN Ultrasonic Scaler by TTBIO CORP.
• POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 by TPC ADVANCED TECHNOLOGY, INC.
• Ultrasonic Scaler Cover by Steri-Shield Products, Inc.
• Meet Endo-II Integrated Endo System by DENJOY DENTAL CO., LTD

• 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

• Ultrasonic Scaler Insert DF100/30K L

  Class II

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

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