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 Teeth, Porcelain
510(k) Number K884214
Device Name CRYSTAR(TM) VINTAGE PORCELAIN
Applicant
Shofu Dental Corp.
4024 Bohannon Dr.
Menlo Park,  CA  94025
Applicant Contact MARTY DYMEK
Correspondent
Shofu Dental Corp.
4024 Bohannon Dr.
Menlo Park,  CA  94025
Correspondent Contact MARTY DYMEK
Regulation Number872.3920
Classification Product Code
ELL  
Date Received10/06/1988
Decision Date 12/08/1988
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
-
-