Mectron K8

• FDA 510(k) K151248 decided 4 Sep 2015 Active
• FDA GUDID UDI-DI E322029001090010 listed 30 Aug 2016 Listed

1. 4 Sep 2015 Cleared FDA 510(k) K151248
2. 30 Aug 2016 Listed FDA GUDID E322029001090010

Trade name

Mectron

Generic name

Ultrasonic surgical system torque wrench, reusable

Model / Ref / Catalog

K8, 02900109-001

Primary DI / UDI-DI

E322029001090010

510(k) Number

K151248 ↗

FDA product code

ELC, DZI

GMDN term

Ultrasonic surgical system torque wrench, reusable

Device class

Class II

Regulation number

872.4850, 872.4120

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Ultrasonic surgical system torque wrench, reusable

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

• Pneumatic Dental Scaler by Innovate, Inc.
• Scaletron Piezo Ultrasonic Scaler by Pac-Dent International (Suzhou), Ltd.
• Amdent 2030 Polisher/Scaler by Amdent AB
• HYGIENTIST; CYCLOSON I & II; RETROFIT by Fibra Sonics, Inc.
• Diamondcoat Ultrasonic Inserts by Dentsply International
• EDS Ultrasonic Tips by Essential Dental Systems
• Sonendo GentleWave System by SONENDO, INC.
• Endo Ultrasonic Activator by Foshan COXO Medical Instrument Co., Ltd.
• Ultrasonic Scaler, Varios 560 by NAKANISHI INC.
• CONDOR ULTRASONIC INSERTS by Condor Products, Inc.

• Mectron OP1125

  Class II

  FDA 510(k) K151248 Active Cleared 4 Sep 2015 GUDID on market

• Mectron OP1225

  Class II

  FDA 510(k) K151248 Active Cleared 4 Sep 2015 GUDID on market

• Mectron EX0410

  Class II

  FDA 510(k) K151248 Active Cleared 4 Sep 2015 GUDID on market

• Mectron EX0510

  Class II

  FDA 510(k) K151248 Active Cleared 4 Sep 2015 GUDID on market

See all devices from Mectron SpA →