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 Alloy, Other Noble Metal
510(k) Number K925331
Device Name CORRECT AND CORRECT FIT II
Applicant
Jeneric/Pentron, Inc.
53 N. Plains Industrial Rd.
P.O. Box 724
Wallingford,  CT  06492
Applicant Contact ARUN PRASAD
Correspondent
Jeneric/Pentron, Inc.
53 N. Plains Industrial Rd.
P.O. Box 724
Wallingford,  CT  06492
Correspondent Contact ARUN PRASAD
Regulation Number872.3060
Classification Product Code
EJS  
Date Received10/21/1992
Decision Date 05/27/1993
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
-
-