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 Powder, Porcelain
510(k) Number K955070
Device Name OPTIBOND; OPTIAID, OPTIREP, OPTISHINE, OPTICHROMA, OPTIFARB & OPTIWAK
Applicant
Optimal Dental (Usa)
1819 S. May St., 2f
Chicago,  IL  60608
Applicant Contact ROBERT W BAUER
Correspondent
Optimal Dental (Usa)
1819 S. May St., 2f
Chicago,  IL  60608
Correspondent Contact ROBERT W BAUER
Regulation Number872.6660
Classification Product Code
EIH  
Date Received11/06/1995
Decision Date 12/11/1995
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
-
-