FDA.reportPublic FDA data

DentMix

Primary DI
00810053771051
Brand
DentMix
Company
IPB
Model
IMD50107-DM
Device description
Clear Bite Registration Fast Set Cartridge
Published
2022-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810053771051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810053771051008100537710518100537710510810053771051

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
784984267
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810053771891PrimeLocLOC50003-102022-12-15
00810053771037DentMixIMD50046-10-DM2022-11-02
00810053771044DentMixIMD50046-24-DM2022-11-02
00810053771068DentMixIMD50107-2-DM2022-11-02
00810053771075DentMixIMD50107-4-DM2022-11-02
00810053771082DentMixIMD50107-10-DM2022-11-02
00810053771099DentMixIMD50107-24-DM2022-11-02
00810053771150DentMixIMD50040-DM2022-11-02
00810053771167DentMixIMD50040-2-DM2022-11-02
00810053771174DentMixIMD50040-4-DM2022-11-02
00810053771181DentMixIMD50040-10-DM2022-11-02
00810053771198DentMixIMD50040-24-DM2022-11-02
00810053771204DentMixIMD50114-50-DM2022-11-02
00810053771211DentMixIMD50115-50-DM2022-11-02
00810053771228DentMixIMD50116-100-DM2022-11-02
00810053771235DentMixIMD500422022-11-02
00810053771242DentMixIMD500432022-11-02
00810053771259DentMixIMD500442022-11-02
00810053771266DentMixIMD50047-DM2022-11-02
00810053771273DentMixIMD50048-DM2022-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800024205816Delikit 7.0 Light Body FastSherpakoreaELW2023-01-16
08800024205908Delikit 7.0 Extra Light Body FastSherpakoreaELW2023-01-16
08800024204420Delikit 7.0 Light Body RegularSherpakoreaELW2023-01-12
08800024204451Delikit 3.0 Light BodySherpakoreaELW2023-01-12
08800024204468Delikit 3.0 Light Body FastSherpakoreaELW2023-01-12
08800024204475Delikit 3.0 Extra Light Body FastSherpakoreaELW2023-01-12
08800024205397Delikit Putty Eco Fast SetSherpakoreaELW2023-01-12
08800024203805Delikit 3.0 Light BodySherpakoreaELW2022-09-15
08800024203997Delikit 3.0 Light Body FastSherpakoreaELW2022-09-15
07640181478934AFFINISColtène/Whaledent AGELW2022-03-27
07640181478958AFFINISColtène/Whaledent AGELW2022-03-27
07640181478972AFFINISColtène/Whaledent AGELW2022-03-27
07640181479030AFFINISColtène/Whaledent AGELW2022-03-27
07640181479054AFFINISColtène/Whaledent AGELW2022-03-27
07640181479061AFFINISColtène/Whaledent AGELW2022-03-27
07640181479115AFFINISColtène/Whaledent AGELW2022-03-27
07640181479146AFFINISColtène/Whaledent AGELW2022-03-27
07640181479153AFFINISColtène/Whaledent AGELW2022-03-27
07640181479160AFFINISColtène/Whaledent AGELW2022-03-27
07640181479177AFFINISColtène/Whaledent AGELW2022-03-27
07640181479214AFFINISColtène/Whaledent AGELW2022-03-27
07640181479238AFFINISColtène/Whaledent AGELW2022-03-27
07640181479245AFFINISColtène/Whaledent AGELW2022-03-27
07640181479290AFFINISColtène/Whaledent AGELW2022-03-27
07640181479306AFFINISColtène/Whaledent AGELW2022-03-27
07640181479313AFFINISColtène/Whaledent AGELW2022-03-27
07640181479481AFFINIS BLACKColtène/Whaledent AGELW2022-03-27
07640181479528AFFINIS BLACKColtène/Whaledent AGELW2022-03-27
07640181479597PRESIDENT The OriginalColtène/Whaledent AGELW2022-02-11
07640181479603PRESIDENT The OriginalColtène/Whaledent AGELW2022-02-11