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 Aligner, Sequential
510(k) Number K080246
Device Name COMPOSITE ALIGNER BUTTON
Applicant
DENTSPLY INTERNTIONAL
221 W. PHILADELPHIA ST. STE.60
SUSQUEHANNA COMMERCE CRT. WEST
YORK,  PA  17405
Applicant Contact HELEN LEWIS
Correspondent
DENTSPLY INTERNTIONAL
221 W. PHILADELPHIA ST. STE.60
SUSQUEHANNA COMMERCE CRT. WEST
YORK,  PA  17405
Correspondent Contact HELEN LEWIS
Regulation Number872.5470
Classification Product Code
NXC  
Date Received01/31/2008
Decision Date 04/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-