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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact JOHN DISCKO
Classification Product Code
MVL  
Date Received05/13/2011
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
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