RE / STASIS (TM) GINGIVAL RETRACTION PASTE


Device Classification Name

cord, retraction

510(k) Number K111348
Device Name RE / STASIS (TM) GINGIVAL RETRACTION PASTE
Applicant
CENTRIX, INC.
770 river rd.
shelton, 
CT 
06484 -5458

Applicant Contact john discko
Correspondent
CENTRIX, INC.
770 river rd.
shelton, 
CT 
06484 -5458

Correspodent Contact john discko
Classification Product Code
MVL  
Date Received 05/13/2011
Decision Date 07/22/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No