Renamel® Nano™ +plus
Renamel Nano +plus is a light-cured composite resin for dental restorations. It combines multifunctional acrylic monomers with silicaceous fillers and is intended to provide a tooth-like…
Renamel Nano +plus is a light-cured composite resin for dental restorations. It combines multifunctional acrylic monomers with silicaceous fillers and is intended to provide a tooth-like appearance in the oral cavity.
Applications include Class I through V restorations, direct veneers on anterior teeth, splinting, and repair of composite or ceramic restorations. The material is placed into the prepared site and hardened with light.
Delivery and Curing
The composite comes in preloaded screw-fed 5 g syringes and 0.25 g unit-dose compules. Material is extruded onto a suitable pad before placement. Compatible curing lights include LED and halogen units operating in the 400 to 500 nm wavelength range.
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 | Cosmedent, Inc., United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Repacker / relabeller |
| 510(k) | K163480 |
| Record published | 2017-05-12 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6006S3 | 10 | In distribution | |
| 6006A1 | 10 | In distribution | |
| 6005A2 | In distribution | ||
| 6006C1 | 10 | In distribution | |
| 600535 | In distribution | ||
| 6005MI | In distribution | ||
| 6006S2 | 10 | In distribution | |
| 6006A3 | 10 | In distribution | |
| 6005D2 | In distribution | ||
| 6006A2 | 10 | In distribution | |
| 6005A1 | In distribution | ||
| 6006D2 | 10 | In distribution | |
| 6005WI | In distribution | ||
| 6006B2 | 10 | In distribution | |
| 6006C3 | 10 | In distribution | |
| 6005B1 | In distribution | ||
| 6005S3 | In distribution | ||
| 6006B0 | 10 | In distribution | |
| 6005S10 | In distribution | ||
| 6006A4 | 10 | In distribution | |
| 6005C3 | In distribution | ||
| 6005C40 | In distribution | ||
| 6006C2 | 10 | In distribution | |
| 6005B0 | In distribution | ||
| 6005A3 | In distribution | ||
| 6005D3 | In distribution | ||
| 6006LI | 10 | In distribution | |
| 6005B2 | In distribution | ||
| 6005S20 | In distribution | ||
| 6005C2 | In distribution | ||
| 6006B1 | 10 | In distribution | |
| 6005LI | In distribution | ||
| 6005A4 | In distribution | ||
| 6006C4 | 10 | In distribution | |
| 6006S1 | 10 | In distribution | |
| 6006MI | 10 | In distribution | |
| 600635 | 10 | In distribution | |
| 6006WI | 10 | In distribution | |
| 6005C1 | In distribution | ||
| 6006D3 | 10 | In distribution |
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 |
|---|---|
| K222435 | 2022-10-11 |
| K211259 | 2021-06-24 |
| K172707 | 2017-12-05 |
| K163480 | 2017-02-24 |
| K092730 | 2009-11-20 |
| K070583 | 2007-04-16 |
| K040994 | 2004-06-03 |
| K993658 | 2000-01-18 |
| K993659 | 2000-01-18 |
| K980800 | 1998-11-09 |
| K921820 | 1992-06-16 |
| K854755 | 1986-03-13 |
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.