FDA.reportPublic FDA data

OpaFit

Primary DI
D815OPAFIT2LC1
Brand
OpaFit
Company
OPA DENTAL LLC
Model
OPAFIT2LC
Catalog number
OPAFIT2LC
Device description
VPS Light Body 50g x 2 Cartridge Dental impression material
Published
2018-09-20
Public version status
Update
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
D815OPAFIT2LC1PrimaryHIBCC0
D815OPAFIT2LC01Unit of UseHIBCC0

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
053308044
Device count
2
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
D815VCR9814DARK0VEICRRVCR9814DARKVCR9814DARK2024-06-10
D815VCR9814LIGHT0VEICRRVCR9814LIGHTVCR9814LIGHT2024-06-10
D815VCR9820DARK0VEICRRVCR9820DARKVCR9820DARK2024-06-10
D815VCR9820LIGHT0VEICRRVCR9820LIGHTVCR9820LIGHT2024-06-10
D815OPAFILL4DO0OPAOPAFILL4DOOPAFILL4DO2023-12-14
D815OPAFILL4DR0OPAOPAFILL4DROPAFILL4DR2023-12-14
D815OPAFILL4P20OPAOPAFILL4P2OPAFILL4P22023-12-14
D815OPAFLOW2DO0OPAOPAFLOW2DOOPAFLOW2DO2023-12-14
D815OPAFLOW2DR0OPAOPAFLOW2DROPAFLOW2DR2023-12-14
D815OPAFLOW2LR0OPAOPAFLOW2LROPAFLOW2LR2023-12-14
D815OPAFLOW2LT0OPAOPAFLOW2LTOPAFLOW2LT2023-12-14
D815OPAFLOW2P10OPAOPAFLOW2P1OPAFLOW2P12023-12-14
D815OPAFLOW2P20OPAOPAFLOW2P2OPAFLOW2P22023-12-14
D815OPAFLOW2W0OPAOPAFLOW2WOPAFLOW2W2023-12-14
PMMA9825CLEAR0LunaPMMA9825CLEARPMMA9825CLEAR2017-04-18
PMMA9520A00LunaPMMA9520A0PMMA9520A02017-04-18
D815PMMA10020A20LunaPMMA10020A2PMMA10020A22017-02-11
D815PMMA10020B10LunaPMMA10020B1PMMA10020B12017-02-11
D815PMMA4019A01LunaPMMA4019A0PMMA4019A02017-02-11
D815PMMA4019A11LunaPMMA4019A1PMMA4019A12017-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18016200010298IQ - alginato non cromatico verde tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200010496IQ TROPICAL - alginato cromatico tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200010748IQ - alginato chrom viola/lilla/verde tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200011318Mono7LASCOD SPAELW2026-05-27
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