Jet Flow Bulk Universal
Meta Biomed Co., Ltd. · Model 6004 · UDI-DI 08806387860044
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-09 | Henry Schein Inc. | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. |
| 2026-07-09 | Henry Schein Inc. | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. |
| 2024-08-02 | Ultradent Products, Inc. | Due to a manufacturing issue, red particulates present in the expressed composite. |
| 2024-08-02 | Ultradent Products, Inc. | Due to a manufacturing issue, red particulates present in the expressed composite. |
| 2024-08-02 | Ultradent Products, Inc. | Due to a manufacturing issue, red particulates present in the expressed composite. |
| 2020-08-31 | Ultradent Products, Inc. | Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. |
| 2019-07-09 | Voco GmbH | The metal cannula are potentially too loose and may become loose when applying the filing material. |
| 2019-01-31 | RHONDIUM LIMITED | The product was mislabeled with an incorrect expiration date. |
| 2017-08-03 | Ivoclar Vivadent, Inc. | Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing |
| 2017-08-03 | Ivoclar Vivadent, Inc. | Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing |
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