Infinix Flowable Composite

Primary DI
07290017528281
Brand
Infinix Flowable Composite
Company
NOBIO LTD
Model
INF-FL-FP-SD-A3
Device description
Dental Composite - A3 shade Single 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
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532282466
Device count
15
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
17290017528288Infinix Flowable CompositeINF-FL-FP-SD-A32021-03-15
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

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