OVC Hybrid
Package contains an OVC Hybrid in shade A2 for tooth number FDI 34.35 XL : USA 20-21 XL (Extra-Large) , 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band, 1 x Hex…
Package contains an OVC Hybrid in shade A2 for tooth number FDI 34.35 XL : USA 20-21 XL (Extra-Large) , 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band, 1 x Hex Stick and 1 x OVC Replica.
10manufacturers in China registered for this device type
79catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Guangdong (3), Shandong (2), Jilin (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | Rhondium Limited, New Zealand |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Manufacturer |
| Record published | 2017-09-21 |
| Record revised | 2019-03-28 (version 5) |
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 |
| Storage | Storage environment temperature 1 to 25 °C |
| Distribution end date | 2019-03-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OVC3 Hybrid FDI 24.25 L: USA 12-13 L A2 | Large | In distribution |
| OVC3 Hybrid FDI 34.35 M : USA 20-21 M A3 | Medium | Withdrawn |
| OVC3 Hybrid FDI 14.15 M : USA 4-5 M A2 | Medium | Withdrawn |
| OVC3 Hybrid FDI 14.15 XS : USA 4-5 XS A3 | Extra-small | Withdrawn |
| OVC3 Hybrid FDI 26.27 XL : USA 14-15 XL A3 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 24.25 XL : USA 12-13 XL A3 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 14.15 L : USA 4-5 L A3 | Large | Withdrawn |
| OVC3 Hybrid FDI 14.15 XL : USA 4-5 XL A2 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 34.35 XL : USA 20-21 XL A2 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 24.25 L: USA 12-13 L A3 | Large | Withdrawn |
| OVC3 Hybrid FDI 34.35 S : USA 20-21 S A3 | Small | Withdrawn |
| OVC3 Hybrid FDI 44.45 M : USA 28-29 M A2 | Small | Withdrawn |
| OVC3 Hybrid FDI 44.45 XL : USA 28-29 XL A3 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 36.37 M : USA 18-19 M A2 | Medium | Withdrawn |
| OVC3 Hybrid FDI 26.27 XL : USA 14-15 XL A2 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 16.17 L : USA 2-3 L A3 | Large | Withdrawn |
| OVC3 Hybrid FDI 14.15 XS : USA 4-5 XS A2 | Extra-small | Withdrawn |
| OVC3 Hybrid FDI 26.27 S : USA 14-15 S A3 | Small | Withdrawn |
| OVC3 Hybrid FDI 36.37 XS : USA 18-19 XS A3 | Extra-Small | Withdrawn |
| OVC3 Hybrid FDI 34.35 XL : USA 20-21 XL A3 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 44.45 XS : USA 28-29 XS A3 | Extra-Small | Withdrawn |
| OVC3 Hybrid FDI 34.35 XS : USA 20-21 XS A3 | Extra-Small | Withdrawn |
| OVC3 Hybrid FDI 16.17 L : USA 2-3 L A2 | Large | Withdrawn |
| OVC3 Hybrid FDI 16.17 XS : USA 2-3 XS A2 | Extra- Small | Withdrawn |
| OVC3 Hybrid FDI 16.17 M : USA 2-3 M A3 | Medium | Withdrawn |
| OVC3 Hybrid FDI 46.47 L : USA 30-31 L A2 | Large | Withdrawn |
| OVC3 Hybrid FDI 16.17 S : USA 2-3 S A3 | Small | Withdrawn |
| OVC3 Hybrid FDI 34.35 S : USA 20-21 S A2 | Small | Withdrawn |
| OVC3 Hybrid FDI 34.35 XS : USA 20-21 XS A2 | Extra-Small | Withdrawn |
| OVC3 Hybrid FDI 24.25 XS: USA 12-13 XS A3 | Extra-Small | Withdrawn |
| OVC3 Hybrid FDI 36.37 XL : USA 18-19 XL A2 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 46.47 XS : USA 30-31 XS A2 | Extra-Small | Withdrawn |
| OVC3 Hybrid FDI 24.25 S: USA 12-13 S A2 | Small | Withdrawn |
| OVC3 Hybrid FDI 24.25 S: USA 12-13 S A3 | Small | Withdrawn |
| OVC3 Hybrid FDI 16.17 M : USA 2-3 M A2 | Medium | Withdrawn |
| OVC3 Hybrid FDI 44.45 S : USA 28-29 S A2 | Small | Withdrawn |
| OVC3 Hybrid FDI 44.45 XS : USA 28-29 XS A2 | Extra-Small | Withdrawn |
| OVC3 Hybrid FDI 26.27 M : USA 14-15 M A2 | Medium | Withdrawn |
| OVC3 Hybrid FDI 44.45 XL : USA 28-29 XL A2 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 16.17 S : USA 2-3 S A2 | Small | Withdrawn |
| OVC3 Hybrid FDI 26.27 XS : USA 14-15 XS A2 | Extra-Small | Withdrawn |
| OVC3 Hybrid FDI 34.35 M : USA 20-21 M A2 | Medium | Withdrawn |
| OVC3 Hybrid FDI 26.27 L : USA 14-15 L A2 | Large | Withdrawn |
| OVC3 Hybrid FDI 14.15 S : USA 4-5 S A3 | Extra-small | Withdrawn |
| OVC3 Hybrid FDI 46.47 M : USA 30-31 M A3 | Medium | Withdrawn |
| OVC3 Hybrid FDI 14.15 M : USA 4-5 M A3 | Medium | Withdrawn |
| OVC3 Hybrid FDI 36.37 XL : USA 18-19 XL A3 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 24.25 M: USA 12-13 M A3 | Medium | Withdrawn |
| OVC3 Hybrid FDI 26.27 M : USA 14-15 M A3 | Medium | Withdrawn |
| OVC3 Hybrid FDI 36.37 S : USA 18-19 S A2 | Small | Withdrawn |
| OVC3 Hybrid FDI 36.37 L : USA 18-19 L A3 | Large | Withdrawn |
| OVC3 Hybrid FDI 14.15 S : USA 4-5 S A2 | Small | Withdrawn |
| OVC3 Hybrid FDI 46.47 S : USA 30-31 S A2 | Small | Withdrawn |
| OVC3 Hybrid FDI 34.35 L : USA 20-21 L A2 | Large | Withdrawn |
| OVC3 Hybrid FDI 36.37 M : USA 18-19 M A3 | Medium | Withdrawn |
| OVC3 Hybrid FDI 34.35 L : USA 20-21 L A3 | Large | Withdrawn |
| OVC3 Hybrid FDI 24.25 M: USA 12-13 M A2 | Medium | Withdrawn |
| OVC3 Hybrid FDI 16.17 XS : USA 2-3 XS A3 | Extra- Small | Withdrawn |
| OVC3 Hybrid FDI 46.47 L : USA 30-31 L A3 | Large | Withdrawn |
| OVC3 Hybrid FDI 14.15 XL : USA 4-5 XL A3 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 14.15 L : USA 4-5 L A2 | Large | Withdrawn |
| OVC3 Hybrid FDI 46.47 XS : USA 30-31 XS A3 | Extra-Small | Withdrawn |
| OVC3 Hybrid FDI 46.47 XL : USA 30-31 XL A2 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 44.45 L : USA 28-29 L A2 | Large | Withdrawn |
| OVC3 Hybrid FDI 24.25 XL : USA 12-13 XL A2 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 36.37 S : USA 18-19 S A3 | Small | Withdrawn |
| OVC3 Hybrid FDI 16.17 XL : USA 2-3 XL A2 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 44.45 S : USA 28-29 S A3 | Small | Withdrawn |
| OVC3 Hybrid FDI 44.45 M : USA 28-29 M A3 | Small | Withdrawn |
| OVC3 Hybrid FDI 46.47 M : USA 30-31 M A2 | Medium | Withdrawn |
| OVC3 Hybrid FDI 16.17 XL : USA 2-3 XL A3 | Extra-Large | Withdrawn |
| OVC3 Hybrid FDI 26.27 L : USA 14-15 L A3 | Large | Withdrawn |
| OVC3 Hybrid FDI 26.27 S : USA 14-15 S A2 | Small | Withdrawn |
| OVC3 Hybrid FDI 24.25 XS: USA 12-13 XS A2 | Extra-Small | Withdrawn |
| OVC3 Hybrid FDI 36.37 L : USA 18-19 L A2 | Large | Withdrawn |
| OVC3 Hybrid FDI 44.45 L : USA 28-29 L A3 | Large | Withdrawn |
| OVC3 Hybrid FDI 36.37 XS : USA 18-19 XS A2 | Extra-Small | Withdrawn |
| OVC3 Hybrid FDI 46.47 S : USA 30-31 S A3 | Small | Withdrawn |
| OVC3 Hybrid FDI 26.27 XS : USA 14-15 XS A3 | Extra-Small | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. | 4,808 |
| Gradia® | GC America Inc. | 548 |
| G-CAM | Graphenano Dental, SL | 320 |
| Vitavm LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 261 |
| G-aenial™ | GC America Inc. | 225 |
| Ena HRI ® | Micerium SPA | 221 |
| Mazic Duro | Vericom Co., Ltd. | 206 |
| Ceramage | Shofu Dental Corp. | 204 |
| Filtek™ | 3M Company | 188 |
| SR Nexco | Ivoclar Vivadent Aktiengesellschaft | 181 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 166 |
| Tetric EvoCeram | Ivoclar Vivadent Aktiengesellschaft | 163 |
Showing 12 of 2,059. All products under Material, Tooth Shade, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143694 | 2015-05-15 |
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 |
|---|---|---|---|---|
| 2019-01-31 | Class II | Employee error | The product was mislabeled with an incorrect expiration date. | 6 devices |
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.