FDA.reportPublic FDA data

OPA

Primary DI
D815OPAFLOW2DO0
Brand
OPA
Company
OPA DENTAL LLC
Model
OPAFLOW2DO
Catalog number
OPAFLOW2DO
Device description
Composite Restorative Flowable 2g DO
Published
2023-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D815OPAFLOW2DO0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
053308044
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
D815VCR9814DARK0VEICRRVCR9814DARKVCR9814DARK2024-06-10
D815VCR9814LIGHT0VEICRRVCR9814LIGHTVCR9814LIGHT2024-06-10
D815VCR9820DARK0VEICRRVCR9820DARKVCR9820DARK2024-06-10
D815VCR9820LIGHT0VEICRRVCR9820LIGHTVCR9820LIGHT2024-06-10
D815OPAFILL4DO0OPAOPAFILL4DOOPAFILL4DO2023-12-14
D815OPAFILL4DR0OPAOPAFILL4DROPAFILL4DR2023-12-14
D815OPAFILL4P20OPAOPAFILL4P2OPAFILL4P22023-12-14
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
D815PMMA4019A21LunaPMMA4019A2PMMA4019A22017-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518340651Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809518340668Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809254453875Dual CoreVERICOM CO., LTD.EBF2026-05-27
08809254453943Dual CoreVERICOM CO., LTD.EBF2026-05-27
07615208291964Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291971Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291988Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291995Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292008Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292015Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292022Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292039Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292046Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292053Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292060Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292077Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292084Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292091Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292107Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292114Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292121Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208006605SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-23
07615208006162SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006179SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006186SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006193SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006209SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006216SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006223SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006230SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22