CLEARSPLINT ES


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

Correspodent Contact douglas s muller
Classification Product Code
MQC  
Date Received 06/28/2011
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