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 Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K011521
Device Name ORTHO VLC; ORTHO VLC CAPSULE
Applicant
First Scientific Limited
7 Roseheyworth Business Park
Abertillery
Blaenau Gwent, Wales,  GB NP13 1SP
Applicant Contact ADE AKINMADE
Correspondent
First Scientific Limited
7 Roseheyworth Business Park
Abertillery
Blaenau Gwent, Wales,  GB NP13 1SP
Correspondent Contact ADE AKINMADE
Regulation Number872.3750
Classification Product Code
DYH  
Date Received05/17/2001
Decision Date 08/01/2001
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
-
-