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 Material, Tooth Shade, Resin
510(k) Number K851929
Device Name RESTORE*
Applicant
Johnson & Johnson Professionals, Inc.
20 Lake Dr.
Cn 7060
East Windsor,  NJ  08520
Applicant Contact CAROL E LANDSMAN
Correspondent
Johnson & Johnson Professionals, Inc.
20 Lake Dr.
Cn 7060
East Windsor,  NJ  08520
Correspondent Contact CAROL E LANDSMAN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/02/1985
Decision Date 07/31/1985
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
-
-