• 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 Denture, Plastic, Teeth
510(k) Number K931162
Device Name KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH
Applicant
King Dental Corp.
10544 NW 26th St.,
Suite 203
Miami,  FL  33172
Applicant Contact JIM BRIGGS
Correspondent
King Dental Corp.
10544 NW 26th St.,
Suite 203
Miami,  FL  33172
Correspondent Contact JIM BRIGGS
Regulation Number872.3590
Classification Product Code
ELM  
Date Received03/08/1993
Decision Date 05/27/1993
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
-
-