• 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 K875143
Device Name RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE)
Applicant
Reliance Orthodontic Products, Inc.
P.O. Box 678
Itasca,  IL  60143
Applicant Contact PAUL A GANGE
Correspondent
Reliance Orthodontic Products, Inc.
P.O. Box 678
Itasca,  IL  60143
Correspondent Contact PAUL A GANGE
Regulation Number872.3750
Classification Product Code
DYH  
Date Received12/15/1987
Decision Date 02/26/1988
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
-
-