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Data / Medical devices / United States / Centrix, Inc.

Centrix, Inc.: FDA-registered device maker in Shelton, CT, United States, 31 510(k) clearances

Centrix, Inc. is registered with the FDA (registration 1281412) in Shelton, CT, United States. It lists 19 device types. The FDA files 31 510(k) clearances under its listings, the newest dated November 21, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Centrix, Inc.
FDA registration number
1281412
Address
770 River Rd, Shelton, CT, United States, 06484
Owner or operator
Centrix, Inc. (1281412)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
August 10, 1992
Registered through
2026
Brand names listed
Access Edge Flo retraction paste, Access Edge retraction paste, AccuDose Tubes, NeedleTubes & Tips, AutoMix Syringe DS50, DS25, Benda Brush, Benda Micro, C-R Syringe Mark I, Mark II, Mark IIIP, S/Class, C-R Syringe Snap-Fit, Snub Nose, NuGun, E/Z, Jumbo, CENTRIX SYRINGE KITS MARK I and more

Devices it lists

DeviceProduct codeClassRoleSource
Agent, Tooth Bonding, ResinKLE2Repackager or relabeleraccessdata.fda.gov
Applicator, ResinKXR1Contract manufacturer, Manufactureraccessdata.fda.gov
Cement, DentalEMA2Repackager or relabeleraccessdata.fda.gov
Cord, RetractionMVLUManufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Repackager or relabeleraccessdata.fda.gov
Device, Caries DetectionLFC2Manufactureraccessdata.fda.gov
Diammine Silver Fluoride Dental Hypersensitivity VarnishPHR2Manufactureraccessdata.fda.gov
Disk, AbrasiveEHJ1Manufactureraccessdata.fda.gov
Handle, Instrument, DentalEJB1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Contract manufacturer, Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Contract manufactureraccessdata.fda.gov
Liner, Cavity, Calcium HydroxideEJK2Repackager or relabeleraccessdata.fda.gov
Material, ImpressionELW2Repackager or relabeler, Specification developeraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Repackager or relabeleraccessdata.fda.gov
Strip, Polishing AgentEHM1Repackager or relabeleraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Manufactureraccessdata.fda.gov
Varnish, CavityLBH2Repackager or relabeler, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 21, 2025K250714FluoroDose VarnishLBHSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
October 27, 2023K222459Centrix FluoroSilver Silver Diamine Fluoride 38%PHRSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
October 15, 2020K200764STATSTIXMVLSubstantially EquivalentCentrix Incorporatedaccessdata.fda.gov
May 27, 2016K152826NoCordELWSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
July 8, 2014K140144BENDA WEDGEEJBSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
July 25, 2012K120176SENZZZZZ AWAYLBHSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
July 22, 2011K111348RE / STASIS (TM) GINGIVAL RETRACTION PASTEMVLSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
February 13, 2009K083438BIFIX SEEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
June 7, 2007K070723FUTURABOND DC/SINGLE DOSEKLESubstantially EquivalentVoco GmbHaccessdata.fda.gov
March 21, 2003K024287FIXOBRIDGE 3-CEMENTEMASubstantially EquivalentAdvanced Healthcare , Ltd.accessdata.fda.gov
April 12, 2002K020287DENTITION INTEGRATING MATERIALEBCSubstantially EquivalentPulpdent Corporationaccessdata.fda.gov
July 21, 2000K001050CALCIJECTEJKSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
November 15, 1996K963927TEAM CARIES INDICATORLFCSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
July 2, 1996K960667CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDEEBFSubstantially EquivalentWallace A. Erickson & Co.accessdata.fda.gov
December 28, 1995K955279D-SENSEKLESubstantially EquivalentCentrix, Inc.accessdata.fda.gov
September 29, 1995K952728RETRACELWSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
April 13, 1994K941124STRUCTUR 2EBGSubstantially EquivalentVoco GmbHaccessdata.fda.gov
January 28, 1994K932829CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PASTEBFSubstantially EquivalentAlpha-Dentaccessdata.fda.gov
January 28, 1994K932826CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUOEBFSubstantially EquivalentAlpha-Dentaccessdata.fda.gov
January 7, 1994K930248VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEMELWSubstantially EquivalentCrown Delta Corp.accessdata.fda.gov
May 27, 1993K931084TEMPITEMASubstantially EquivalentCentrix, Inc.accessdata.fda.gov
March 31, 1993K926418CLIPEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
September 1, 1992K921174COMPOSITE RESIN CORE PASTE MATERIALEBFSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
August 10, 1992K922638TEMPIT-EEMASubstantially EquivalentCentrix, Inc.accessdata.fda.gov
February 25, 1992K915618PROVICOLEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
October 5, 1990K903551TEMPOREXEBFSubstantially EquivalentScientific Pharmaceuticals, Inc.accessdata.fda.gov
March 29, 1989K890140PHOSPHORIC-ACID ETCHING GELEBFSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
August 17, 1987K873002MIN-IDENTOFLEXEHJSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
October 19, 1983K832781CURAY-SUPPORT, CORE BUILD-UP MATERIALEBFSubstantially EquivalentScientific Pharmaceuticals, Inc.accessdata.fda.gov
December 28, 1982K823510CURAY ANTERIOR/POSTERIOR RESTORATIVEEBFSubstantially EquivalentScientific Pharmaceuticals, Inc.accessdata.fda.gov
March 17, 1981K810479SUPPORTEBFSubstantially EquivalentSci-Pharm, Inc.accessdata.fda.gov

Compare with other makers

Updated November 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.