Rdh-2000

510(k) Number

K023213 ↗

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, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE by A-Dec, Inc.
• EUROCART SR-4, EUROCART M-IV, ISOCART III by Sds Dental, Inc.
• PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE by Pall Medical
• SiroCam AF 6309400 by SIRONA Dental Systems GmbH
• TENEO Dental Treatment Unit and Accessories by SIRONA Dental Systems GmbH
• TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE by ASI MEDICAL, INC.
• Midmark Dental Delivery System by Midmark Corporation
• K5 Cart, K5 Mount, K5 Swing by Osstem Implant Company., Ltd. Chair Business
• Aseptico AEU-350S-W by ASEPTICO, INC.
• DENTIST WITH ASSISTANT PACK by Sterile Concepts, 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 →