FDA Registration
Active
🇺🇸 United States
CENTRIX, INC.
Reg #: 1281412
·
FEI: 1281412
·
Expires 2026
Products
19
Proprietary Names
35
Establishment Types
4
Classifications
19
Registration Details
- Registration Name
- CENTRIX, INC.
- Registration Number
- 1281412
- FEI Number
- 1281412
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 770 River Rd
- City
- Shelton
- State
- CT
- ZIP
- 06484
- Country
- US
Regulatory Submissions
- 510(k) Number
- K001050
Owner / Operator
- Firm Name
- Centrix, Inc.
- Operator Number
- 1281412
- Address
- 770 RIVER RD., --
- City
- Shelton
- State
- CT
- Postal Code
- 06484
- Country
- US
- Correspondent
- Tim - White
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2007-10-08 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2007-10-08 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2007-11-07 |
| Cord, Retraction | MVL | Class U | Unknown | No | 2016-06-03 |
| Material, Impression | ELW | Class 2 | Dental | No | 2016-06-03 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2007-10-08 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2007-10-08 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2012-10-18 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 1992-08-10 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2013-05-28 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2023-11-05 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2011-02-24 |
| Device, Caries Detection | LFC | Class 2 | Dental | No | 2007-11-07 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2011-05-17 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2023-08-29 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 1992-08-10 |
| Diammine Silver Fluoride Dental Hypersensitivity Varnish | PHR | Class 2 | Dental | No | 2023-11-05 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 1998-08-31 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2011-12-15 |
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
StatStix
Lube Cube
Versalite
Glu/sense
Versaflo
FluoroDose
SuperCure
Encore AF Natural W/Fluoride
Encore Natural W/Fluoride
GripStrip Inter-Proximal Polisher
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)