C-1890

510(k) Number

K023896 ↗

FDA product code

EIA

Device class

Class I

Regulation

21 CFR Part 872.6640

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 EIA (Unit, Operative Dental).

• A-DEC SELF-CONTAINED WATER SYSTEM by A-Dec, Inc.
• WAGGONER DENTAL MANUFACTURING STERIWATER SYSTEM by Waggoner Dental Mfg.
• MODEL GDCH-2000 by Global Dental Direct, Inc.
• ALLPAC(TM) MATERIAL by Barrier Concepts, Inc.
• A-DEC 200 DENTAL SYSTEM by A-Dec, Inc.
• CHALLENGE-EVER by Hallim Dentech Co., Ltd.
• ULTRACAM II by Dental Vision Direct, Inc.
• OKTAS INTRA-ORAL DENTAL CAMERA by Oktas
• OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS K5 by OSSTEM IMPLANT Co., Ltd.
• INTEGO 6427285 by SIRONA Dental Systems GmbH

• 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 →