FDA.reportPublic FDA data

Access VPS

Primary DI
00817051021119
Brand
Access VPS
Company
CENTRIX, INC.
Model
360016
Device description
Access VPS Heavy impression material
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00817051021119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817051021119008170510211198170510211190817051021119

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
053707303
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817051020457Onyx3100522016-09-23
00817051020464Onyx3100532016-09-23
00817051020471Onyx3100542016-09-23
00817051020488Onyx3100552016-09-23
00817051023847Fluorodose3601402025-03-17
00817051023854Fluorodose3601432025-03-17
10817051023844Fluorodose3601422025-03-17
20817051023841Fluorodose3601412025-03-17
00817051022963StatStix3800642023-12-29
00817051022970StatStix3800652023-12-29
00817051020303Access Edge3601132016-09-23
00817051020310Access Edge3601142016-09-23
00817051020327Access Flo3601222016-09-23
00817051020334Access Flo3601232016-09-23
00817051021225GingiTrac3600682016-09-23
00817051021232GingiTrac3600692016-09-23
00817051021249GingiTrac3601002016-09-23
00817051021256GingiTrac3601012016-09-23
00817051021263GingiTrac3601022016-09-23
00817051021270GingiTrac7000022016-09-23

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