• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997

  • Print
  • Share
  • E-mail
-
See Related
Database Updated 09/29/2014

This page provides information on persons accredited (as of the above date of revision) to review selected premarket notifications [510(k)s] and the devices they may review.  Information on this list will be updated within 10 working days after the date reflected on the third party's accreditation letter.  Each classified device type on the list of devices eligible for Third Party Review has one or more product codes associated with it.  Devices eligible for review by Third Parties are limited to the product codes shown on the list of eligible devices.  Please refer to the List of Devices for Third Party Review Under the FDA Modernization Act (FDAMA) of 1997 to assure your device is eligible for the Accredited Person Program. To-date, FDA has not withdrawn accreditation from any Accredited Person.
BSI HEALTHCARE
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
DEKRA CERTIFICATION B.V.
NIOM - NORDIC INSTITUTE OF DENTAL MATERIALS
REGULATORY TECHNOLOGY SERVICES, LLC
THIRD PARTY REVIEW GROUP, LLC
TUV SUD AMERICA INC.
NIOM - NORDIC INSTITUTE OF DENTAL MATERIALS
KIRKEVEIEN 71B
P.O. BOX 70
HASLUM NO-1305    
NORWAY
Contact: STIG KARLSSON
Phone:476 751 2200
Fax: 759 1530
PanelSection Number       Regulation Name / Device Name      Class
Dental
  872.1800 Extraoral source x-ray system. II
  872.1810 Intraoral source x-ray system. II
  872.3060 Noble metal alloy. II
  872.3200 Resin tooth bonding agent. II
  872.3275 Dental cement. II
  872.3660 Impression material. II
  872.3690 Tooth shade resin material. II
  872.3710 Base metal alloy. II
  872.4200 Dental handpiece and accessories. I
  872.6250 Dental chair and accessories. I
  872.6640 Dental operative unit and accessories. I
  872.6710 Boiling water sterilizer. I
top of page   
-
-