Dental Device Guide
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Manufacturer registered with FDA

Centrix, Inc.

Shelton, CT, United States. Lists 18 dental device types with FDA across 1 registered establishment, and holds 44 510(k) clearances as applicant.

FDA owner/operator1281412Contract manufacturerManufacturerRepacker / relabelerSpecification developer2 clearances in five years
Device types listed
18
Brands and models
33
510(k) clearances
441979–2025
Markets registered in
11193 registrations outside the US
Establishments
1United States
1979: 11981: 11983: 11984: 11985: 11986: 11987: 11988: 21989: 31992: 41993: 21994: 31995: 21996: 31997: 41998: 41999: 12000: 12001: 12002: 22012: 12014: 12016: 12023: 12025: 119801990200020102020

510(k) clearances per year, 1976–2026

Registered in 11 markets

Where regulators' registries name Centrix, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 18 device types listedCanada: 93 registrationsColombia: 25 registrationsAustralia: 19 registrationsSouth Korea: 17 registrationsUnited Kingdom: 15 registrationsSerbia: 14 registrationsTaiwan: 5 registrationsIsrael: 2 registrationsSaudi Arabia: 2 registrationsCosta Rica: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerCentrix, Inc.44 clearances1979–2025Below
CanadaHealth CanadaRegistration holderCENTRIX INCORPORATED931999–2024Pure Global AI
ColombiaINVIMARegistration holderCENTRIX INC25—Pure Global AI
AustraliaTGAManufacturerCentrix Inc192004–2018Pure Global AI
South KoreaMFDSManufacturerCentrix, IncorporatedCentrix Incorporated · Centrix Inc. · +2171999–2010Pure Global AI
United KingdomMHRAManufacturerCentrix Inc.15—Pure Global AI
SerbiaALIMSManufacturerCentrix Inc.142024–2025Pure Global AI
TaiwanTFDAManufacturerCENTRIX INC52005–2025Pure Global AI
IsraelAMARManufacturerCentrix Inc.2—Pure Global AI
Saudi ArabiaSFDAManufacturerCentrix2—Pure Global AI
Costa RicaMinisterio de SaludManufacturerCENTRIX INC.1—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Centrix, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Tooth Shade MaterialEBF · Class 2Dental compositesMaker
Encore AF Natural W/FluorideEncore AF White w/FluorideEncore C-R HybridEncore D/CEncore Natural W/FluorideEncore Natural W/O FluorideEncore White W/FluorideEncore White W/O FluorideLube CubeOnyx
5 more
SuperCureTempit L/CTempit UltraVersafloVersalite
2007
Dental CementEMA · Class 2Dental cementsLister
Tempit Moisture CureTempit-E
2007
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker
StatStix
2013
Impression MaterialELW · Class 2Impression materialsMaker
GingiTrac
2007
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsLister
Glu/sense
2007
Cavity VarnishLBH · Class 2Sealants & varnishesMaker
D/Sense CrystalFluoroDose
2012
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker—2023
Pit and Fissure Sealant and ConditionerEBC · Class 2Sealants & varnishesLister—2011
Resin Temporary Crown and BridgeEBG · Class 2Temporary crown & bridge materialsLister—2007
Abrasive DiskEHJ · Class 1Polishing & prophylaxisMaker
ProxiDiscs - Smooth
2007
Polishing Agent StripEHM · Class 1Polishing & prophylaxisLister
GripStrip Inter-Proximal Polisher
2011
Preformed Impression TrayEHY · Class 1Impression traysMaker—2023
Restorative and Impression Material SyringeEID · Class 1Dental hand instrumentsMaker
AutoMix Syringe DS50, DS25C-R Syringe Mark I, Mark II, Mark IIIP, S/ClassC-R Syringe Snap-Fit, Snub Nose, NuGun, E/Z, JumboCENTRIX SYRINGE KITS MARK I
1992
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsMaker
AccuDose Tubes, NeedleTubes & Tips
1998
Calcium Hydroxide Cavity LinerEJK · Class 2—Lister
Calciject
2007
Resin ApplicatorKXR · Class 1—Maker
Benda Brush, Benda Micro
1992
Caries Detection DeviceLFC · Class 2Caries detection devicesMaker
Expose'
2007
Diammine Silver Fluoride Dental Hypersensitivity VarnishPHR · Class 2—Maker
SilverSense SDF
2023

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Centrix, Inc. as the applicant.

Decided510(k)DeviceDevice type
21 Nov 2025K250714FluoroDose VarnishLBH Cavity Varnish
27 Oct 2023K222459Centrix FluoroSilver Silver Diamine Fluoride 38%PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish
27 May 2016K152826NoCordELW Impression Material
8 Jul 2014K140144BENDA WEDGEEJB Dental Instrument Handle
25 Jul 2012K120176SENZZZZZ AWAYLBH Cavity Varnish
26 Sep 2002K021131CHLORAPREPLBH Cavity Varnish
2 Jul 2002K021146D/SENSE 1-STEPEJK Calcium Hydroxide Cavity Liner
5 Apr 2001K010133VERSALUXEBZ Ultraviolet Activator for Polymerization
21 Jul 2000K001050CALCIJECTEJK Calcium Hydroxide Cavity Liner
22 Oct 1999K992629D/SENSE II (GREEN-OR) DENTIN DESENSITIZERLBH Cavity Varnish
7 Dec 1998K981972GREEN-OR DENTIN DESENSITIZERLBH Cavity Varnish
8 Sep 1998K982665JUMBO SILVER-REINFORCED GLASS IONOMEREMA Dental Cement
30 Apr 1998K980568JUMBO GLASS IONOMER CEMENTEMA Dental Cement
25 Feb 1998K973285D/SENSE-TKLE Resin Tooth Bonding Agent
17 Nov 1997K973257VERSAETCHEBF Resin Tooth Shade Material
27 Jun 1997K971121ENCORE BONDKLE Resin Tooth Bonding Agent
14 Feb 1997K965138DENTINSENSE B/CKLE Resin Tooth Bonding Agent
5 Feb 1997K964735DENTINSENSEKLE Resin Tooth Bonding Agent
15 Nov 1996K963927TEAM CARIES INDICATORLFC Caries Detection Device
7 Oct 1996K963311TEAM ETCHEBF Resin Tooth Shade Material
23 Apr 1996K961190GLY-ETCHEBC Pit and Fissure Sealant and Conditioner
28 Dec 1995K955279D-SENSEKLE Resin Tooth Bonding Agent
29 Sep 1995K952728RETRACELW Impression Material
4 Apr 1994K935151HYDROCOLLOID HEATING UNITELW Impression Material
18 Jan 1994K933507NEEDLETUBE SYRINGE CARTRTIDGEEJK Calcium Hydroxide Cavity Liner
5 Jan 1994K933999STERIBASE (ACCUBASE)EJK Calcium Hydroxide Cavity Liner
15 Sep 1993K926368APPLICATOR NOZZLEEKJ Operative Burnisher
27 May 1993K931084TEMPITEMA Dental Cement
4 Nov 1992K921173TYPE 1 DENTAL CEMENTEMA Dental Cement
1 Sep 1992K921174COMPOSITE RESIN CORE PASTE MATERIALEBF Resin Tooth Shade Material
10 Aug 1992K922638TEMPIT-EEMA Dental Cement
25 Feb 1992K913974ACCESS IMPRESSION BARRELEID Restorative and Impression Material Syringe
29 Mar 1989K890140PHOSPHORIC-ACID ETCHING GELEBF Resin Tooth Shade Material
10 Feb 1989K890064DENTAL SYRINGE APPLICATION TIPEKJ Operative Burnisher
10 Jan 1989K885162BENDA BRUSHEKJ Operative Burnisher
11 Aug 1988K882125CENTRIX TRI-LAMINATE POST SYSTEMELR Root Canal Post
10 Aug 1988K882651CENTRIX NEEDLETUBEEKJ Operative Burnisher
17 Aug 1987K873002MIN-IDENTOFLEXEHJ Abrasive Disk
12 May 1986K861581CENTRIX PCR MOLAR MATRIX FORMS (BANDS)DZN Dental Hand Instruments
23 Aug 1985K853282CENTRIX RIBBON TUBESEID Restorative and Impression Material Syringe
30 Mar 1984K833725PRE-LOADED C-R TUBES FOR SYRINGEEBF Resin Tooth Shade Material
4 Oct 1983K832662DENTAL SYRINGE SYSTEM-VARIOUS STYLESKXR Resin Applicator
8 Sep 1981K811831MULTI-PURPOSE DENTAL SYRINGEEJI Cartridge Syringe
19 Dec 1979K792461CENTRIX MKIV ENDODONTIC DELIVERYEIC Irrigating Endodontic Periodontic Syringe

Some of these clearances are listed with FDA today by another company: Advanced Healthcare , Ltd. (2), NuSmile, Ltd. (1), Garrison Dental Solutions LLC (1).

Also lists devices cleared under other names

Centrix, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Voco GmbH (5), Scientific Pharmaceuticals (3), Alpha-Dent (2), Advanced Healthcare , Ltd. (1), Pulpdent Corporation (1), Wallace A. Erickson & Co. (1), Crown Delta Corp. (1), Sci-Pharm, Inc. (1).

Decided510(k)DeviceApplicantDevice type
13 Feb 2009K083438BIFIX SEVoco GmbHEMA Dental Cement
7 Jun 2007K070723FUTURABOND DC/SINGLE DOSEVoco GmbHKLE Resin Tooth Bonding Agent
21 Mar 2003K024287FIXOBRIDGE 3-CEMENTAdvanced Healthcare , Ltd.EMA Dental Cement
12 Apr 2002K020287DENTITION INTEGRATING MATERIALPulpdent CorporationEBC Pit and Fissure Sealant and Conditioner
2 Jul 1996K960667CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDEWallace A. Erickson & Co.EBF Resin Tooth Shade Material
13 Apr 1994K941124STRUCTUR 2Voco GmbHEBG Resin Temporary Crown and Bridge
28 Jan 1994K932826CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUOAlpha-DentEBF Resin Tooth Shade Material
28 Jan 1994K932829CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PASTAlpha-DentEBF Resin Tooth Shade Material
7 Jan 1994K930248VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEMCrown Delta Corp.ELW Impression Material
31 Mar 1993K926418CLIPVoco GmbHEBF Resin Tooth Shade Material
25 Feb 1992K915618PROVICOLVoco GmbHEMA Dental Cement
5 Oct 1990K903551TEMPOREXScientific PharmaceuticalsEBF Resin Tooth Shade Material
19 Oct 1983K832781CURAY-SUPPORT, CORE BUILD-UP MATERIALScientific PharmaceuticalsEBF Resin Tooth Shade Material
28 Dec 1982K823510CURAY ANTERIOR/POSTERIOR RESTORATIVEScientific PharmaceuticalsEBF Resin Tooth Shade Material
17 Mar 1981K810479SUPPORTSci-Pharm, Inc.EBF Resin Tooth Shade Material

Registered establishments

EstablishmentLocationWhat it does
CENTRIX, INC.FDA reg. 1281412Shelton, CT, United StatesContract manufacturer, Manufacturer, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1281412). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.