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 Powder, Porcelain
510(k) Number K981000
Device Name CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN
Applicant
European Dental Imports, Inc.
49 Emerson Rd.
Durham,  NH  03824
Applicant Contact MICHAEL H EVERNGAM
Correspondent
European Dental Imports, Inc.
49 Emerson Rd.
Durham,  NH  03824
Correspondent Contact MICHAEL H EVERNGAM
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/18/1998
Decision Date 05/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-