N!ce for Planmill
n!ce for PlanMill is a glass-ceramic block milled to make dental restorations for natural teeth or implant abutments. It consists of lithium aluminosilicate ceramic reinforced with lithium…
n!ce for PlanMill is a glass-ceramic block milled to make dental restorations for natural teeth or implant abutments. It consists of lithium aluminosilicate ceramic reinforced with lithium disilicate. The material is supplied fully crystallized and can be shaped into inlays, onlays, veneers, partial crowns or crowns.
The block is bonded to a mandrel compatible with PlanMill material holders. High-translucency and low-translucency versions are described. The C14 block measures 12.4 by 14.5 by 18.0 mm, providing the machining blank for the planned restoration.
Listed Item
n!ce® for PlanMill®, HT Bleach, C14
Restoration Thickness
The specified minimum wall thickness of the milled restoration is 1.0 mm. The material is classified as a Type II, Class 2 dental ceramic. The PlanMill version changes the equipment-compatible mandrel while retaining the glass-ceramic material of the earlier n!ce blocks.
Who Else Makes It
Concentrated in Guangdong (10), Hunan (6), Hebei (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BMF Tech (Zhuhai) Inc. | Zhuhai | Guangdong | Contract manufacturer | 2 |
| Jiangxi Rekonova Dental Materials Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 1 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| 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 |
| Shenzhen Yurucheng Dental Materials Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. | Zhangzhou | Henan | Manufacturer | 6 |
Showing 12 of 33. All 33 manufacturers in China registered for Powder, Porcelain
Record
| Listed by | Institut Straumann AG, Switzerland |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K173410 |
| Record published | 2019-05-21 |
| Record revised | 2023-10-25 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution | |
| Milling Materials | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bloomden | Bloomden Bioceramics (Hunan) Co., Ltd. | 6,340 |
| Upcera Dental Zirconia Blank For Aesthetic Restoration | Liaoning Upcera Co., Ltd. | 4,367 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 4,310 |
| Luxen 5G | Dentalmax Co., Ltd. | 3,903 |
| GC Initial™ | GC America Inc. | 2,724 |
| Gradual Dental Zirconia Blank | Liaoning Upcera Co., Ltd. | 2,035 |
| Multi M Series | Dmax Co., Ltd. | 1,854 |
| Zirconia Dental Ceramics | Chengdu Besmile Medical Technology Co., Ltd. | 1,828 |
| Amber® Mill Q | Hass Corp. | 1,602 |
| Upcera Dental Zirconia Pre-Shaded Blank | Liaoning Upcera Co., Ltd. | 1,498 |
| BruxZir | Prismatik Dentalcraft, Inc. | 1,295 |
| ceraMotion® | Dentaurum GmbH & Co. KG | 1,062 |
Showing 12 of 10,017. All products under Powder, Porcelain
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173410 | 2017-11-14 |
| K170420 | 2017-03-02 |
| K160262 | 2016-09-16 |
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.