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

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
08809263708607MX 02-1508602026-10-28
08809263708614MX 02-2008612026-10-28
08809263708621MX 02-2508622026-10-28
08809263708638MX 02-3008632026-10-28
08809263708645MX 02-3508642026-10-28
08809263708652MX 02-4008652026-10-28
08809263708720MX 04-1508722026-10-28
08809263708737MX 04-2008732026-10-28
08809263708744MX 04-2508742026-10-28
08809263708751MX 04-3008752026-10-28
08809263708768MX 04-3508762026-10-28
08809263708775MX 04-4008772026-10-28
08809263708843MX 06-1508842026-10-28
08809263708850MX 06-2008852026-10-28
08809263708867MX 06-2508862026-10-28
08809263708874MX 06-3008872026-10-28
08809263708881MX 06-3508882026-10-28
08809263708898MX 06-4008892026-10-28
08809263708904MG 02-1508902026-10-28
08809263708911MG 02-2008912026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00766054003045BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003052BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003069BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003076BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003083BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003090BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003106BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003113BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003120BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003137BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
EDMG2228071Ecosite Elements Pure Refill B1DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228081Ecosite Elements Pure Refill A2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228091Ecosite Elements Pure Refill A3DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228101Ecosite Elements Pure Refill A3.5DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228121Ecosite Elements Layer Refill EBDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228131Ecosite Elements Layer Refill ELDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228141Ecosite Elements Layer Refill EMDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228151Ecosite Elements Layer Refill EDDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228161Ecosite Elements Highlight Refill IncisalDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228171Ecosite Elements Highlight Refill OA2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228181Ecosite Elements Highlight Refill WhiteDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228191Ecosite Elements Highlight Refill BrownDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228201Ecosite Elements Pure Refill B1DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228211Ecosite Elements Pure Refill A2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228221Ecosite Elements Pure Refill A3DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228231Ecosite Elements Pure Refill A3.5DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228251Ecosite Elements Layer Refill EBDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228261Ecosite Elements Layer Refill ELDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228271Ecosite Elements Layer Refill EMDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228281Ecosite Elements Layer Refill EDDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30