Ultrasonic Scaler Insert DP100/25K L

• FDA 510(k) K011179 decided 5 Jun 2001 Active
• FDA GUDID UDI-DI 07290016281460 listed 24 Sep 2016 Listed

1. 5 Jun 2001 Cleared FDA 510(k) K011179
2. 24 Sep 2016 Listed FDA GUDID 07290016281460

Trade name

Ultrasonic Scaler Insert

Generic name

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Model / Ref / Catalog

DP100/25K L, 508806

Primary DI / UDI-DI

07290016281460

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).

• SPARTAN MTS by Spartan Marketing Group
• SP NEWTRON MODULE by Satelec
• EMS KERMIT by Electro Medical Systems (Ems Sa)
• ULTRASONIC TOOTH SCALER MODEL DSCIOP by PARKELL, INC.
• Parkell® DSG30P by PARKELL, INC.
• HARMO SONIC by U.S. Shizai Corp.
• Model 3003 Scaler by Dentsply Intl.
• Engler 25K Series Ultrasonic Inserts by Engler Engineering Corp.
• Loving Touch LT:200 Ultrasonic Scaler by Litton Dental Products
• Bonart ART-M3II & M4 Ultrasonic Scaler Units with Accessories by BONART CO., LTD.

• 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 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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