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 K060530
Device Name SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.
Applicant
Lifecore Biomedical, Inc.
3515 Lyman Blvd.
Chaska,  MN  55318
Applicant Contact RACHEL KENNEDY
Correspondent
Lifecore Biomedical, Inc.
3515 Lyman Blvd.
Chaska,  MN  55318
Correspondent Contact RACHEL KENNEDY
Regulation Number872.3920
Classification Product Code
ELL  
Date Received02/28/2006
Decision Date 05/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-