Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K000710
Device Name MD 10, SEM, SM 12, CBM
Applicant
NOUVAG AG
Sudetenstr. 5
Kaufbeuren,  DE D87600
Applicant Contact MARGIT ESCHBAUMER
Correspondent
NOUVAG AG
Sudetenstr. 5
Kaufbeuren,  DE D87600
Correspondent Contact MARGIT ESCHBAUMER
Regulation Number872.4200
Classification Product Code
EFB  
Date Received03/02/2000
Decision Date 05/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-