Steri-Sol Solution, Modification

510(k) Number

K925378 ↗

FDA product code

EFB

Device class

Class I

Regulation

21 CFR Part 872.4200

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code EFB (Handpiece, Air-Powered, Dental).

• MICRO-DISPENSER 7000 & MICRODISPENSER 8000 by Nouvag AG
• High-speed air turbine handpiece / Low-speed air turbine handpiece by Foshan Wenjian Medical Instrument Co., Ltd.
• LARES 757 WORKHORSE HIGHSPEED HANDPIECE by Lares Research, Inc.
• LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS by Lares Research, Inc.
• MK-dent ECO LINE HE20K by MK-Dent GmbH
• CENTURY MODEL 105C by Sybron Dental Specialties, Inc.
• EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES by TTBIO CORP.
• W&H 898 TOP LIGHT HIGHSPEED by A-Dec, Inc.
• PRODRIVE LINE OF DENTAL HANDPIECES by Prodrive Systems, Inc.
• W&H MICRO AIR MOTOR LT25 by A-Dec, Inc.

• Zoral Scaler Solution® MAK-Z4

  Class I

  FDA 510(k) K925378 Active Cleared 22 Jul 1993 GUDID on market

• WaterlineX® (01)854542008167(10)204008

  Class I

  FDA 510(k) K023896 Active Cleared 19 Jun 2003 GUDID on market

• Pro-Kleen 854542008037

  Class I

  FDA 510(k) K023815 Active Cleared 19 Jun 2003 GUDID on market

• DentaKLEEN® (01)00854542008150(10)3030951384

  Class I

  FDA 510(k) K023815 Active Cleared 19 Jun 2003 GUDID on market

See all devices from Anodia Systems →