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 Activator, Ultraviolet, For Polymerization
510(k) Number K023652
Device Name REMECURE MODEL CL 15E
Applicant
Remedent NV
20992 Bake Pkwy.
Unit 102
Lake Forest,  CA  92692
Applicant Contact ED FIRST
Correspondent
Remedent NV
20992 Bake Pkwy.
Unit 102
Lake Forest,  CA  92692
Correspondent Contact ED FIRST
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received10/30/2002
Decision Date 01/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-