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 Unit, Operative Dental
510(k) Number K974238
Device Name DENTAL TRAY, STERILE, DISPOSABLE
Applicant
Trinity Laboratories, Inc.
201 Kiley Dr.
Salisbury,  MD  21801
Applicant Contact PARTHA BASUMALLIK
Correspondent
Trinity Laboratories, Inc.
201 Kiley Dr.
Salisbury,  MD  21801
Correspondent Contact PARTHA BASUMALLIK
Regulation Number872.6640
Classification Product Code
EIA  
Date Received11/12/1997
Decision Date 02/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-