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 Bracket, Metal, Orthodontic
510(k) Number K901024
Device Name STAINLESS STEEL DENTAL WIRES AND CLASPS
Applicant
Ivoclar North America, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Applicant Contact GARY L SEVERANCE
Correspondent
Ivoclar North America, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact GARY L SEVERANCE
Regulation Number872.5410
Classification Product Code
EJF  
Date Received03/06/1990
Decision Date 04/25/1990
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
-
-