Centrix Endo Kit

Primary DI
00817051021218
Brand
Centrix Endo Kit
Company
CENTRIX, INC.
Model
360053
Device description
Centrix Endo Kit root canal pack
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817051021218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817051021218008170510212188170510212180817051021218

GMDN Terms#

Term, Definition table
TermDefinition
Calcium hydroxide suspensionA very basic (high pH) calcium hydroxide (Ca(OH)2) solution (also known as slaked lime or milk of lime) used in dentistry for a variety of purposes including to flush and disinfect root canals and crowns/bridges before final insertion, and to change the viscosity and/or moisten a temporary tooth filling material. It may also encourage the change of fibroblasts (cells which form the connective tissue of the body) into odontoblast-like cells to produce reparative dentin. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
053707303
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817051023847Fluorodose3601402025-03-17
00817051023854Fluorodose3601432025-03-17
10817051023844Fluorodose3601422025-03-17
20817051023841Fluorodose3601412025-03-17
00817051021461SuperMixer9106262023-12-29
00817051021478SuperMixer9106282023-12-29
00817051021485SuperMixer9106322023-12-29
00817051021850Tempit3100312023-12-29
00817051021881Mark I1106152023-12-29
00817051021898EZ1307152023-12-29
00817051021904Snap Fit1316502023-12-29
00817051021911Mark II1406152023-12-29
00817051021942Jumbo1806152023-12-29
00817051021959Accudose2100012023-12-29
00817051021980Accudose2900032023-12-29
00817051022000Accudose2900212023-12-29
00817051022024Accudose2900232023-12-29
00817051022031Accudose2400012023-12-29
00817051022048Accudose2900012023-12-29
00817051022055Accudose2500032023-12-29

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00815967029694RodinPac-Dent, Inc.EMA2026-03-23
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00815967029717RodinPac-Dent, Inc.EMA2026-03-23
00815967029724RodinPac-Dent, Inc.EMA2026-03-23
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