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 Cement, Dental
510(k) Number K081887
Device Name LUTE-IT II VENEER CEMENT, MODEL NO6
Applicant
Pentron Clinical Technologies
68-70 N. Plains Industrial
Rd.
Wallingford,  CT  06492
Applicant Contact GREG MOREAU
Correspondent
Pentron Clinical Technologies
68-70 N. Plains Industrial
Rd.
Wallingford,  CT  06492
Correspondent Contact GREG MOREAU
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/02/2008
Decision Date 08/29/2008
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
-
-