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 Material, Impression
510(k) Number K013236
Device Name LUXABITE
Applicant
DMG USA, INC.
5 WHITCOMB AVE.
AYER,  MA  01432
Applicant Contact PAMELA PAPINEAU
Correspondent
DMG USA, INC.
5 WHITCOMB AVE.
AYER,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number872.3660
Classification Product Code
ELW  
Date Received09/28/2001
Decision Date 10/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-