FDA.reportPublic FDA data

START VPS

Primary DI
00816594021310
Brand
START VPS
Company
DANVILLE MATERIALS, LLC
Model
80006-01
Catalog number
80006-01
Device description
START VPS,HEAVY,STIFF,ECON KIT
Published
2016-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00816594021310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816594021310008165940213108165940213100816594021310

GMDN Terms#

Term, Definition table
TermDefinition
Polyether dental impression materialAn elastomeric, polyether-based material capable of reacting to form a rubber-like substance used 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature074 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(760)743-7744xxx@xxx.xxx

Regulatory Flags#

DUNS number
601302743
Device count
1
DM exempt
true
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
00816594020122ACCOLADE90546905462016-06-22
00816594020238ACCOLADE90551905512016-06-22
00816594021655PRELUDE90976909762016-06-22
00816594021662PRELUDE90974909742016-06-22
00816594021679PRELUDE94036940362016-06-22
00816594021686PRELUDE94072940722016-06-22
00816594021693PRELUDE94037940372016-06-22
00816594021709PRELUDE91653916532016-06-22
00816594021716PRELUDE91657916572016-06-22
00816594021723PRELUDE90972909722016-06-22
00816594021730PRELUDE94035940352016-06-22
00816594021747PRELUDE91024910242016-06-22
00816594021754PRELUDE90990909902016-06-22
00816594021761PRELUDE90994909942016-06-22
00816594021839S-BOND89104891042016-06-22
00816594021907ZBOND93410934102016-06-22
00816594023369PONTIC90138901382016-09-20
00816594020825TURBO TEMP 290156901562016-06-22
00816594020832TURBO TEMP 292964929642016-06-22
00816594020849TURBO TEMP 290158901582016-06-22

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