Jet Flow Bulk A2

GUDID 08806387860068

- 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.

Meta Biomed Co., Ltd.

Dental composite resin

• Primary Device ID: 08806387860068
• NIH Device Record Key: 7571e94b-9dc0-4bca-8afd-52e577c8581c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jet Flow Bulk A2
• Version Model Number: 6006
• Company DUNS: 688322841
• Company Name: Meta Biomed Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806387860068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242014

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-25
• Device Publish Date: 2024-11-16

Devices Manufactured by Meta Biomed Co., Ltd.

• 08806387860044 - Jet Flow Bulk Universal: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 08806387860051 - Jet Flow Bulk A1: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 08806387860068 - Jet Flow Bulk A2: 2024-11-25- 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.
• 08806387860068 - Jet Flow Bulk A2: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 08806387860075 - Jet Flow Bulk A3: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 08806387860136 - Jet Flow Bulk Dentin: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 08806387860129 - EZ Bond Universal (EZB50): 2024-06-13 EZ Bond Universal is dentin adhesion system that functions as a conditioner, primer and adhesive resin in a single component. EZ
• 08806387860105 - CeraPutty CP10: 2023-11-23 CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent
• 08806387860112 - CeraPutty CP05: 2023-11-23 CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent