FDA.reportPublic FDA data

Infinix Flowable Composite

Primary DI
17290017528288
Brand
Infinix Flowable Composite
Company
NOBIO LTD
Model
INF-FL-FP-SD-A3
Device description
Dental Composite - A3 shadeSingle dose
Published
2021-03-15
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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201010000Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeNobio , Ltd.2020-08-14EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017528288PrimaryGS10
07290017528281Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001752828817290017528288
07290017528281072900175282817290017528281

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.

Regulatory Flags#

DUNS number
532282466
Device count
15
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290017528073Infinix Universal CompositeINF-UC-FP-SD-A32021-03-15
17290017528080Infinix Universal CompositeINF-UC-FP-SD-B12021-03-15
07290017528335Infinix Universal Bond - PrimerINF-PR-PP-MD2.5ML2021-03-18
07290017528298Infinix Universal Bond- BondINF-BOND-PP-MD2.5ML2021-03-18
07290017528304Infinix Universal Bond - BondINF-BOND-PP-MD5ML2021-03-18
07290017528342Infinix Universal Bond - PrimerINF-PR-PP-MD5ML2021-03-18
17290017528370Infinix Universal Bond - PrimerINF-PR-PP-MD2.5ML2021-03-18
17290017528059Infinix Universal CompositeINF-UC-FP-SD-A12021-03-15
17290017528066Infinix Universal CompositeINF-UC-FP-SD-A22021-03-15
17290017528097Infinix Universal CompositeINF-UC-FP-SD-TR2021-03-15
17290017528165Infinix Bulk Fill Flow CompositeINF-BF-FP-SD-A12021-03-15
17290017528172Infinix Bulk Fill Flow CompositeINF-BF-FP-SD-A22021-03-15
17290017528189Infinix Bulk Fill Flow CompositeINF-BF-FP-SD-A32021-03-15
17290017528264Infinix Flowable CompositeINF-FL-FP-SD-A12021-03-15
17290017528271Infinix Flowable CompositeINF-FL-FP-SD-A22021-03-15
17290017528431Infinix Bulk Fill Flow CompositeINF-BF-FP-SD-TR2021-03-15
07290017528007Infinix Universal CompositeINF-UC-PP-MD-A12021-03-15
07290017528014Infinix Universal CompositeINF-UC-PP-MD-A22021-03-15
07290017528038Infinix Universal CompositeINF-UC-PP-MD-B12021-03-15
07290017528045Infinix Universal CompositeINF-UC-PP-MD-TR2021-03-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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