BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP


Device Classification Name

cement, dental

510(k) Number K103585
Device Name BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP
Applicant
HARRY J. BOSWORTH CO.
7227 north hamlin ave.
skokie, 
IL 
60076

Applicant Contact gary chuven
Correspondent
HARRY J. BOSWORTH CO.
7227 north hamlin ave.
skokie, 
IL 
60076

Correspodent Contact gary chuven
Regulation Number 872.3275
Classification Product Code
EMA  
Subsequent Product Code
EBF  
Date Received 12/07/2010
Decision Date 03/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No