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 K070045
Device Name ZIRBLANK-PS AND ZIRBLANK-FS
Applicant
ACUCERA, INC.
539 JINBUL-LI
JINJEOP, NAMYANGJU
GYEONGGI,  KR 472-861
Applicant Contact KYUNG-BIN LEE
Correspondent
ACUCERA, INC.
539 JINBUL-LI
JINJEOP, NAMYANGJU
GYEONGGI,  KR 472-861
Correspondent Contact KYUNG-BIN LEE
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/04/2007
Decision Date 03/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-