Bifix Veneer Try-In
Bifix Veneer Try-In is a water-soluble, coloured glycerine paste. The shade appearance of the cured Bifix Veneer LC can be simulated by inserting the permanent restoration with Bifix Veneer…
Bifix Veneer Try-In is a water-soluble, coloured glycerine paste. The shade appearance of the cured Bifix Veneer LC can be simulated by inserting the permanent restoration with Bifix Veneer Try-In in the selected shade, syringe 2.5g bright.
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
Record
| Listed by | Voco Gmbh, Germany |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K252606 |
| Record published | 2026-03-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 28 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1432 | In distribution | |
| 1430 | In distribution | |
| 1431 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GC Fuji II LC® | GC America Inc. | 78 |
| Equia® | GC America Inc. | 73 |
| Riva SC | SDI Ltd. | 72 |
| Denture Base | American Tooth Industries | 61 |
| Riva LC | SDI Ltd. | 59 |
| GC Fuji IX GP® | GC America Inc. | 58 |
| GlasIonomer FX-LC | Shofu Dental Corp. | 45 |
| Henry Schein | Henry Schein, Inc. | 35 |
| Esthet-X®flow Liquid Micro Hybrid | Dentsply LLC | 24 |
| Photac™ Fil Quick Aplicap™ | 3M Deutschland GmbH | 24 |
| Ketac™ Fil Plus Aplicap™ | 3M Deutschland GmbH | 23 |
| Ultra-Bond® | DEN-MAT Holdings, LLC | 23 |
Showing 12 of 780. All products under Cement, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252606 | 2026-03-20 |
| K220640 | 2022-08-23 |
| K201856 | 2020-08-26 |
| K180386 | 2018-05-08 |
| K160774 | 2016-08-03 |
| K143212 | 2015-05-01 |
| K140993 | 2014-10-20 |
| K130421 | 2013-08-14 |
| K102612 | 2010-11-19 |
| K090817 | 2009-07-23 |
| K083438 | 2009-02-13 |
| K063554 | 2007-01-12 |
| K060894 | 2006-05-02 |
| K042669 | 2004-10-20 |
| K033068 | 2003-10-31 |
| K930116 | 1993-06-17 |
| K926492 | 1993-04-08 |
| K930455 | 1993-04-08 |
| K926458 | 1993-03-31 |
| K922853 | 1992-08-10 |
| K922854 | 1992-08-05 |
| K915618 | 1992-02-25 |
| K915619 | 1992-02-25 |
| K914612 | 1992-02-03 |
| K914073 | 1991-10-21 |
| K912497 | 1991-07-30 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-01-25 | Class II | Process control | Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is | 1021 units |
| 2024-01-25 | Class II | Process control | Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is | 1530 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.