THE INSYNC CERAMIC SYSTEM


Device Classification Name

powder, porcelain

510(k) Number K111743
Device Name THE INSYNC CERAMIC SYSTEM
Applicant
JENSEN INDUSTRIES, INC.
50 stillman rd.
north haven, 
CT 
06473

Applicant Contact gary phelps
Correspondent
JENSEN INDUSTRIES, INC.
50 stillman rd.
north haven, 
CT 
06473

Correspodent Contact gary phelps
Regulation Number 872.6660
Classification Product Code
EIH  
Date Received 06/21/2011
Decision Date 09/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No