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, ceramic, orthodontic
510(k) Number K902075
Device Name INTRIGUE CERAMIC BRACKET
Applicant
LANCER ORTHODONTICS, INC.
6050 AVENIDA ENCINAS
P.O. BOX 819
CARLSBAD,  CA  92008
Applicant Contact MIKE EKINAKA
Correspondent
LANCER ORTHODONTICS, INC.
6050 AVENIDA ENCINAS
P.O. BOX 819
CARLSBAD,  CA  92008
Correspondent Contact MIKE EKINAKA
Regulation Number872.5470
Classification Product Code
NJM  
Date Received05/08/1990
Decision Date 08/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-