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510(k) K111348

Device
RE / STASIS (TM) GINGIVAL RETRACTION PASTE
Applicant
CENTRIX, INC.
510(k) number
K111348
Product code
MVL  
Decision
Substantially Equivalent (SESE)
Decision date
2011-07-22
Date received
2011-05-13
Regulation
510(k) Premarket Notification
Classification name
Cord, Retraction
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Dental
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOHN DISCKO
Address
770 River Rd. Shelton CT US 06484 06484

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MVL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254239CyClean CordSS GLOBAL2026-03-27
K253797One-StopMediclus Co., Ltd.2026-02-27
K243910RetraxilKulzer, LLC2025-09-24
K211420Stasis GelBelport Company, Inc., Gingi-Pak2022-03-14
K211419Gingi-Aid GelBelport Company, Inc., Gingi-Pak2022-01-10
K213149VOCO Retraction PasteVoco GmbH2021-12-09
K200764STATSTIXCentrix Incorporated2020-10-15
K193389Vista ClearInter-Med/Vista Dental Products2020-03-04
K190220Vista FS, Vista FS LiquidInter-Med/Vista Dental Products2019-06-10
K171577Smartcord, Smartcord XEastdent Co., Ltd.2018-05-03
K162662GingiDent Gingival Retraction PastePac-Dent International, Inc.2017-10-20
K162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/MaterialsKerr Corporation2017-08-08
K162536GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction CordKerr Corporation2017-02-03
K162164GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction CordKerr Corporation2017-01-13
K152064Astringedent ClearUltradent Products, Inc.2015-09-24

Legacy Summary#

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FDA Review#

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