FDA.reportPublic FDA data

Infinix Universal Composite

Primary DI
17290017528080
Brand
Infinix Universal Composite
Company
NOBIO LTD
Model
INF-UC-FP-SD-B1
Device description
Dental Composite - B1 shadeSingle dose
Published
2021-03-15
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
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
27290017528087PackageGS120In Commercial Distribution
17290017528080PrimaryGS10
07290017528083Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729001752808727290017528087
1729001752808017290017528080
07290017528083072900175280837290017528083

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
20
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
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
07290017528045Infinix Universal CompositeINF-UC-PP-MD-TR2021-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
07615208476804Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476811Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476828Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476835Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476842Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477658Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477665Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477672Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477689Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477696Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477702Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477719Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477726Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477733Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477740Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477757Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29