Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1281412

FEI Number

1281412

Entity Name

CENTRIX, INC.

City/State/Country

Shelton, CT, US

Establishment Address

770 River Rd, Shelton, CT 06484, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Centrix, Inc. (Owner Number: 1281412)

Owner / Operator Contact Address

770 RIVER RD., --, Shelton, CT 06484, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Calciject Tempit Moisture Cure Encore White W/Fluoride Encore AF White w/Fluoride Tempit Ultra ProxiDiscs - Smooth D/Sense Crystal Tempit L/C Benda Brush, Benda Micro Onyx GingiTrac Access Edge Flo retraction paste Access Edge retraction paste Expose' Tempit-E C-R Syringe Mark I, Mark II, Mark IIIP, S/Class CENTRIX SYRINGE KITS MARK I AutoMix Syringe DS50, DS25 C-R Syringe Snap-Fit, Snub Nose, NuGun, E/Z, Jumbo SilverSense SDF Encore D/C Encore Natural W/O Fluoride Encore White W/O Fluoride Encore C-R Hybrid AccuDose Tubes, NeedleTubes & Tips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2007-10-08
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2007-10-08
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-11-07
MVL	Cord, Retraction	Unknown	Class U	N/A	2016-06-03
ELW	Material, Impression	Dental	Class 2	872.3660	2016-06-03
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-10-08
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-10-08
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-07
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2007-10-08
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2012-10-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-11-10
EMA	Cement, Dental	Dental	Class 2	872.3275	2014-09-04
KXR	Applicator, Resin	Dental	Class 1	872.3140	1992-08-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-10-08
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2013-05-28
ELW	Material, Impression	Dental	Class 2	872.3660	2007-10-08
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2023-11-05
MVL	Cord, Retraction	Unknown	Class U	N/A	2011-12-20
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2011-02-24
LFC	Device, Caries Detection	Dental	Class 2	872.1740	2007-11-07
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2011-05-17
EMA	Cement, Dental	Dental	Class 2	872.3275	2019-01-10
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2023-08-29
EMA	Cement, Dental	Dental	Class 2	872.3275	2020-05-08
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	1992-08-10
PHR	Diammine Silver Fluoride Dental Hypersensitivity Varnish	Dental	Class 2	872.3260	2023-11-05
ELW	Material, Impression	Dental	Class 2	872.3660	2007-10-08
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-10-08
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	1998-08-31

Official Correspondent

Tim White

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Centrix, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K941532	Bio-Probe, Inc.	BIOCALEX 6/9	1994-08-02
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1281412. Last updated year: 2026. Please use registration number 1281412 when referencing this establishment in official correspondence.