• 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 Mouthguard, Prescription
510(k) Number K111828
Device Name CLEARSPLINT ES
Applicant
ASTRON DENTAL CORPORATION
815 OAKWOOD RD. UNIT G
LAKE ZURICH,  IL  60047
Applicant Contact DOUGLAS S MULLER
Correspondent
ASTRON DENTAL CORPORATION
815 OAKWOOD RD. UNIT G
LAKE ZURICH,  IL  60047
Correspondent Contact DOUGLAS S MULLER
Classification Product Code
MQC  
Date Received06/28/2011
Decision Date 10/26/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-