FDA.reportPublic FDA data

Jet Flow Bulk A3

Primary DI
08806387860075
Brand
Jet Flow Bulk A3
Company
Meta Biomed Co., Ltd.
Model
6007
Device description
- Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent enabling up to a depth of 3~5mm at a time.- Jet Flow Bulk is packaged in disposable tips and two syringes that include restorative materials.- The shades offered with Jet Flow Bulk are Universal(U), Dentin(D), A1, A2, A3.- Jet Flow Bulk contains bisGMA, UDMA, bisEMA.- The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.053 to 6.76 microns and silica with a particle size range of 0.04 to 0.452 micro micrometre. The inorganic filler loading is approximately 35.6 vol.% (61.0wt.%).Jet Flow Bulk's models are divided according to color: Jet Flow Bulk Universal, Jet Flow Bulk Dentin, Jet Flow Bulk A1, Jet Flow Bulk A2 and Jet Flow Bulk A3.
Published
2024-11-16
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
EBCSealant, Pit And Fissure, And Conditioner
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242014000Jet Flow BulkMeta Biomed Co., Ltd.2024-10-08EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806387860075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806387860075088063878600758806387860075

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
688322841
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
08806387895190BeneMedik, 1~2mm, 30cc95192016-09-19
08806387895275BeneMedik, 4~6mm, 1cc95272016-09-19
08806387897002BoneMedik-DM, 0.1~0.3mm, 0.25g97002016-09-19
08806387897019BoneMedik-DM, 0.1~0.3mm, 0.5g97012016-09-19
08806387897026BoneMedik-DM, 0.1~0.3mm, 1.0g97022016-09-19
08806387897033Bonemedik-DM, 0.1~0.3mm, 2g97032016-09-19
08806387897040BoneMedik-DM, 0.1~0.3mm, 5g97042016-09-19
08806387897057BoneMedik-DM, 0.1~0.3mm, 10g97052016-09-19
08806387897064BoneMedik-DM 0.3~0.5mm, 0.25g97062016-09-19
08806387897071BoneMedik-DM, 0.3~0.5mm, 0.5g97072016-09-19
08806387897088BoneMedik-DM 0.3~0.5mm, 1.0g97082016-09-19
08806387897095BoneMedik-DM 0.3~0.5mm, 2.0g97092016-09-19
08806387897101BoneMedik-DM, 0.3~0.5mm, 5g97102016-09-19
08806387897118BoneMedik-DM, 0.3~0.5mm, 10g97112016-09-19
08806387897125BoneMedik-DM 0.5~1.0mm, 0.25g97122016-09-19
08806387897132BoneMedik-DM 0.5~1.0mm, 0.5g97132016-09-19
08806387897149BoneMedik-DM 0.5~1.0mm, 1.0g97142016-09-19
08806387897156BoneMedik-DM 0.5~1.0mm, 2.0g97152016-09-19
08806387897163BoneMedik-DM, 0.5~1mm, 5g97162016-09-19
08806387897170BoneMedik-DM, 0.5~1mm, 10g97172016-09-19

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