Henry Schein
Maxima Resin Modified GI Automix, A3.5
3manufacturers in China registered for this device type
35catalogue numbers in this listing
1recall
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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Premarket notification | Exempt |
| Record published | 2020-02-28 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 18 to 29 °C |
| Sizes | Weight 14 to 100 g; total volume 15 to 210 ml; weight 1 lb |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1006200 | In distribution | ||
| 1048788 | In distribution | ||
| 1001492 | Weight 29 g | In distribution | |
| 1008027 | Bottle | In distribution | |
| 1060858 | Glass Ionomer Powder | In distribution | |
| 1000572 | In distribution | ||
| 1006200 | Total Volume 15 ml | In distribution | |
| 1009765 | Weight 29 g | In distribution | |
| 1001131 | In distribution | ||
| 5703021 | In distribution | ||
| 1001540 | Liquid | In distribution | |
| 1001040 | Weight 40 g | In distribution | |
| 1001705 | Weight 1 lb | In distribution | |
| 1005161 | In distribution | ||
| 1007326 | In distribution | ||
| 1000535 | In distribution | ||
| 1048782 | In distribution | ||
| 1068629 | Weight 15 g | In distribution | |
| 1009765 | In distribution | ||
| 5703022 | In distribution | ||
| 1016567 | In distribution | ||
| 1000572 | Total Volume 210 ml | In distribution | |
| 1003605 | In distribution | ||
| 1003605 | Weight 29 g | In distribution | |
| 1000535 | Weight 1 lb | In distribution | |
| 1005344 | Catalyst | In distribution | |
| 5703020 | In distribution | ||
| 9004392 | 50 | In distribution | |
| 1048787 | In distribution | ||
| 1001492 | In distribution | ||
| 1001705 | In distribution | ||
| 1005161 | Weight 29 g | In distribution | |
| 1001131 | Weight 29 g | In distribution | |
| 1007326 | Weight 1 lb | In distribution | |
| 1048783 | 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 |
| 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 |
| TPH®3 flow Liquid Micro Hybrid | Dentsply LLC | 22 |
Showing 12 of 780. All products under Cement, Dental
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-11-10 | Not classified | Pending | The specific lots of Maxcem Elite Refill Kit appear not to be authentic. | 18,855 units total: Domestic – 18,820 units; Foreign – 35 un | 2018-07-03 |
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.