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 Airbrush
510(k) Number K010816
Device Name DENTO-PREP PARTICLE MICROBLASTER
Applicant
RONVIG A/S
GL VEJLEVELJ 57-59
DK-8721 DAUGAARD,  DK DK-8721
Applicant Contact ANNETTE RAVN NIELSEN
Correspondent
RONVIG A/S
GL VEJLEVELJ 57-59
DK-8721 DAUGAARD,  DK DK-8721
Correspondent Contact ANNETTE RAVN NIELSEN
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received03/19/2001
Decision Date 05/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-