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 Denture, Plastic, Teeth
510(k) Number K842208
Device Name NATURA-TONE OR LUXOPAL CL ACRYLIC
Applicant
Parexel Intl. Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Parexel Intl. Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3590
Classification Product Code
ELM  
Date Received06/04/1984
Decision Date 07/31/1984
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
-
-