C-1805M

510(k) Number

K023815 ↗

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).

• SPACELINE DENTAL CHAIR-UNIT by Pacific Dental Corp.
• HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR by Hygenitek, Inc.
• PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE by Pall Medical
• WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM by Welch Allyn, Inc.
• PROSTYLE COMPACT by Planmeca Oy
• MDT/CASTLE PURUS DENTAL UNIT by Mdt Corp., Inc.
• STERILE WATER SYSTEM by Syntex Dental Products, Inc.
• ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES by Rolence Enteprise, Inc.
• INTEGO Family and Accesories by SIRONA Dental Systems GmbH
• OPTUM, INTRAORAL CAMERA SYSTEM by Camsight Co., 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 →