DENTAL WATER SYSTEM
Received Sep 6, 1995
Report MW1006855 · MDR key 25248
Device
Generic name
Water System
Manufacturer
American Dental Accessories, Inc.Product problems
- False claim
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THIS DENTAL WATER SUPPLY SYSTEM IS SUPPOSED TO BE REPROCESSED BY A PROCEDURE THAT INVOLVES AN UNDESIGNATED DISINFECTANT. THERE ARE NO DISINFECTANTS FDA CLEARED FOR THIS PURPOSE. THE REPROCESSING PROCEDURE HAS NOT BEEN CLEARED BY THE FDA & THERE IS NO EVIDENCE THAT IT WORKS. THE PRODUCT IS NOT BEING MARKETED LEGALLY IN THE USA. THERE IS NO EVIDENCE THAT IT IMPROVES THE QUALITY OF WATER DELIVERED BY DENTAL INSTRUMENTS.