OVC™ One Visit Crown
OVC One Visit Crown is a preformed hybrid-ceramic crown for a structurally compromised posterior tooth. A fully cured anatomical chewing surface sits over an uncured resin sublayer that can…
OVC One Visit Crown is a preformed hybrid-ceramic crown for a structurally compromised posterior tooth. A fully cured anatomical chewing surface sits over an uncured resin sublayer that can be customized to the tooth preparation.
Once customized, the crown is bonded to the prepared natural tooth. Designs cover upper and lower premolars and molars, with six size options for each design.
Listed Item
The Starter Kit consists of a set of 40 OVCs in tooth shade A2 – one each for 8 tooth types, upper and lower molar and premolars, in five sizes for each tooth type individually packaged. Each OVC is packaged with 4 x OVC Wedges, a Selector Key and an OVC Replica. Each kit includes an accessory kit – a convenience kit for clinicians containing a procedural aids.
Sizing and Placement Accessories
An OVC Replica made from vinyl polysiloxane reproduces the cured crown portion for position and clearance assessment. Polycarbonate Selector Keys assist sizing, while polyacetal wedges support the working area. Crowns and these accessories are supplied nonsterile for single use.
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 |
| 510(k) | K143694 |
| Record published | 2016-09-24 |
| Record revised | 2018-11-26 (version 4) |
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 | 2017-12-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OVC 20-21 M A3 | Medium | Withdrawn |
| OVC Starter Kit A2 US | Extra small, small, medium, large, extra large | Withdrawn |
| OVC 2-3 S A2 | Small | Withdrawn |
| OVC 2-3 XS A3 | Extra Small | Withdrawn |
| OVC 30-31 XS A3 | Extra Small | Withdrawn |
| OVC 12-13 L A2 | Large | Withdrawn |
| OVC 4-5 S A3 | Small | Withdrawn |
| OVC 18-19 L A2 | Large | Withdrawn |
| OVC 20-21 L A3 | Large | Withdrawn |
| OVC 20-21 L A2 | Large | Withdrawn |
| OVC 20-21 XL A3 | Extra Large | Withdrawn |
| OVC 14-15 S A3 | Small | Withdrawn |
| OVC Molar Kit A2 US | Small, medium, large | Withdrawn |
| OVC 20-21 S A3 | Small | Withdrawn |
| OVC 28-29 XL A2 | Extra Large | Withdrawn |
| OVC 14-15 XL A3 | Extra Large | Withdrawn |
| OVC 28-29 XS A2 | Extra Small | Withdrawn |
| OVC 4-5 M A3 | Medium | Withdrawn |
| OVC Starter Kit A3 US | Extra small, small, medium, large, extra large | Withdrawn |
| OVC 28-29 S A3 | Small | Withdrawn |
| OVC 4-5 XS A3 | Extra Small | Withdrawn |
| OVC 28-29 XL A3 | Extra Large | Withdrawn |
| OVC 12-13 XS A2 | Extra Small | Withdrawn |
| OVC 4-5 L A3 | Large | Withdrawn |
| OVC 2-3 M A3 | Medium | Withdrawn |
| OVC 14-15 XS A3 | Extra Small | Withdrawn |
| OVC Molar Kit A3 US | Small, medium, large | Withdrawn |
| OVC 12-13 M A3 | Medium | Withdrawn |
| OVC 18-19 XS A2 | Extra Small | Withdrawn |
| OVC 14-15 L A2 | Large | Withdrawn |
| OVC Training Kit 18+TM-L A2 US | Withdrawn | |
| OVC 30-31 XL A2 | Extra Large | Withdrawn |
| OVC 28-29 L A3 | Large | Withdrawn |
| OVC 4-5 XL A2 | Extra Large | Withdrawn |
| OVC 14-15 XS A2 | Extra Small | Withdrawn |
| OVC 4-5 S A2 | Small | Withdrawn |
| OVC 28-29 M A2 | Medium | Withdrawn |
| OVC 20-21 XL A2 | Extra Large | Withdrawn |
| OVC 30-31 M A2 | Medium | Withdrawn |
| OVC 18-19 XS A3 | Extra Small | Withdrawn |
| OVC 12-13 XS A3 | Extra Small | Withdrawn |
| OVC 20-21 XS A2 | Extra Small | Withdrawn |
| OVC 30-31 L A3 | Large | Withdrawn |
| OVC 4-5 XL A3 | Extra Large | Withdrawn |
| OVC 18-19 M A2 | Medium | Withdrawn |
| OVC 18-19 XL A3 | Extra Large | Withdrawn |
| OVC Premolar Pack A2 US | Small, medium, large | Withdrawn |
| OVC 12-13 S A2 | Small | Withdrawn |
| OVC 12-13 S A3 | Small | Withdrawn |
| OVC 30-31 S A2 | Small | Withdrawn |
| OVC 12-13 M A2 | Medium | Withdrawn |
| OVC 12-13 XL A3 | Extra Large | Withdrawn |
| OVC 18-19 S A2 | Small | Withdrawn |
| OVC 2-3 S A3 | Small | Withdrawn |
| OVC Training Kit 30+TM-R A2 US | Withdrawn | |
| OVC 18-19 XL A2 | Extra Large | Withdrawn |
| OVC 12-13 XL A2 | Extra Large | Withdrawn |
| OVC 30-31 S A3 | Small | Withdrawn |
| OVC 2-3 M A2 | Medium | Withdrawn |
| OVC 4-5 M A2 | Medium | Withdrawn |
| OVC 28-29 L A2 | Large | Withdrawn |
| OVC 20-21 XS A3 | Extra Small | Withdrawn |
| OVC 4-5 XS A2 | Extra Small | Withdrawn |
| OVC 14-15 L A3 | Large | Withdrawn |
| OVC 20-21 M A2 | Medium | Withdrawn |
| OVC 18-19 S A3 | Small | Withdrawn |
| OVC 14-15 M A2 | Medium | Withdrawn |
| OVC 28-29 S A2 | Small | Withdrawn |
| OVC 30-31 XL A3 | Extra Large | Withdrawn |
| OVC 12-13 L A3 | Large | Withdrawn |
| OVC 2-3 L A2 | Large | Withdrawn |
| OVC 14-15 M A3 | Medium | Withdrawn |
| OVC Kit A3 No Accessories US | Extra small, small, medium, large, extra large | Withdrawn |
| OVC 4-5 L A2 | Large | Withdrawn |
| OVC Accessory Kit – no Tooth Model US | Withdrawn | |
| OVC 28-29 M A3 | Medium | Withdrawn |
| OVC 14-15 S A2 | Small | Withdrawn |
| OVC 18-19 M A3 | Medium | Withdrawn |
| OVC SML Kit A2 US | Small, medium, large | Withdrawn |
| OVC 28-29 XS A3 | Extra Small | Withdrawn |
| OVC Kit A2 No Accessories US | Extra small, small, medium, large, extra large | Withdrawn |
| OVC SML Kit A3 US | Small, medium, large. | Withdrawn |
| OVC 14-15 XL A2 | Extra Large | Withdrawn |
| OVC 2-3 XL A3 | Extra Large | Withdrawn |
| OVC 2-3 XS A2 | Extra Small | Withdrawn |
| OVC 20-21 S A2 | Small | Withdrawn |
| OVC 30-31 L A2 | Large | Withdrawn |
| OVC 30-31 M A3 | Medium | Withdrawn |
| OVC 30-31 XS A2 | Extra Small | Withdrawn |
| OVC 2-3 XL A2 | Extra Large | Withdrawn |
| OVC 18-19 L A3 | Large | Withdrawn |
| OVC 2-3 L A3 | Large | 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Rhondium Limited | 510(k) number | 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.