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 K143071
Device Name Nacera Pearl
Applicant
DOCERAM MEDICAL CERAMICS GMBH
HESSLINGSWEG 65-67
dortmund, nrw,  DE d-44309
Applicant Contact stefan drude
Correspondent
DOCERAM MEDICAL CERAMICS GMBH
HESSLINGSWEG 65-67
dortmund, nrw,  DE d-44309
Correspondent Contact stefan drude
Regulation Number872.6660
Classification Product Code
EIH  
Date Received10/27/2014
Decision Date 06/26/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-