IonoStar Plus
Fast-setting glass ionomer restorative material.
3manufacturers in China registered for this device type
8catalogue numbers in this listing
26510(k) clearances naming this product code
2recalls on this code
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 |
| Record published | 2016-09-13 |
| Record revised | 2021-10-18 (version 4) |
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 23 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2544 | 20 | In distribution | |
| 2543 | 20 | In distribution | |
| 2547 | 150 | In distribution | |
| 2546 | 150 | In distribution | |
| 2549 | In distribution | ||
| 2545 | 20 | In distribution | |
| 2548 | 20 | In distribution | |
| 2540 | 50 | 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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Voco Gmbh | UDI-DI | 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 |
Recalls
1 of these is 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 |
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.