Unbreakable by TCS
Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base plates for removable dental prosthetic appliances. This includes but is not to be limited to…
Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base plates for removable dental prosthetic appliances. This includes but is not to be limited to full and partial removable dentures, orthodontics devices, occlusal splints, and night guards.
14manufacturers in China registered for this device type
96catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (2), Hebei (1).
| 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 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
| Guangzhou Heygears Imc.inc | Guangzhou | Guangdong | Specification developer | 8 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Resin, Denture, Relining, Repairing, Rebasing
Record
| Listed by | Thermoplastic Comfort SYS |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| 510(k) | K053060 |
| Record published | 2016-08-01 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4000-01/M Custom | 5 | In distribution | |
| 4005-01/M22-3 | 5 | In distribution | |
| 4005-01/L22 Custom | 5 | In distribution | |
| 4003-01B/2X5 | In distribution | ||
| 4005-01/LN | 5 | In distribution | |
| 4005-01/LF4 | 5 | In distribution | |
| 4005-01/LF Custom | 5 | In distribution | |
| 4003-01B/1.5 | In distribution | ||
| 4005-01/L22-N | 5 | In distribution | |
| 4005-01/M22-4 | 5 | In distribution | |
| 4000-01/MF4 | 5 | In distribution | |
| 4000-01/M2 | 5 | In distribution | |
| 4005-01/L Custom | 5 | In distribution | |
| 4005-01/LNZ25-N | 5 | In distribution | |
| 4005-01/M22 Custom | 5 | In distribution | |
| 4000-01/MF Custom | 5 | In distribution | |
| 4003-01B/1X10 | In distribution | ||
| 4000/D98x20-2 | In distribution | ||
| 4005-01/LT25-4 | 5 | In distribution | |
| 4003-01/BN | 5 | In distribution | |
| 4005-01/M22-2 | 5 | In distribution | |
| 4005-01/LF1 | 5 | In distribution | |
| 4003-01/B4 | 5 | In distribution | |
| 4005-01/M22-1 | 5 | In distribution | |
| 4003-01B/4-.5 | In distribution | ||
| 4003-01B/ CustomX5 | In distribution | ||
| 4000-01/M4 | 5 | In distribution | |
| 4002-01/S2 | 5 | In distribution | |
| 4005-01/LNZ25-1 | 5 | In distribution | |
| 4003-01B/4X5 | In distribution | ||
| 4003-01/B1 | 5 | In distribution | |
| 4002-01/SN | 5 | In distribution | |
| 4005-01/MT25 Custom | 5 | In distribution | |
| 4005-JP/L2 | 5 | In distribution | |
| 4003-01B/ Custom-.5 | In distribution | ||
| 4000-01/MN | 5 | In distribution | |
| 4005-01/MT25-1 | 5 | In distribution | |
| 4002-01/S1 | 5 | In distribution | |
| 4005-01/LT25-2 | 5 | In distribution | |
| 4000-01/MF3 | 5 | In distribution | |
| 4002-JP/SN | 5 | In distribution | |
| 4003-01/B3 | 5 | In distribution | |
| 4000-01/M1 | 5 | In distribution | |
| 4003-01B/2X10 | In distribution | ||
| 4005-01/LF2 | 5 | In distribution | |
| 4005-01/L22-4 | 5 | In distribution | |
| 4005-JP/L1 | 5 | In distribution | |
| 4005-01/MT25-3 | 5 | In distribution | |
| 4003-01/B2 | 5 | In distribution | |
| 4005-01/MT25-2 | 5 | In distribution | |
| 4002-JP/S4 | 5 | In distribution | |
| 4003-01B/3X5 | In distribution | ||
| 4005-JP/LN | 5 | In distribution | |
| 4000/D98x25-N | In distribution | ||
| 4005-01/M22-N | 5 | In distribution | |
| 4003-01B/4X10 | In distribution | ||
| 4005-JP/L3 | 5 | In distribution | |
| 4005-01/LT25-1 | 5 | In distribution | |
| 4002-JP/S3 | 5 | In distribution | |
| 4005-01/L22-3 | 5 | In distribution | |
| 4000-01/MFN | 5 | In distribution | |
| 4002-JP/S1 | 5 | In distribution | |
| 4005-01/LT25-3 | 5 | In distribution | |
| 4000/D98x25-2 | In distribution | ||
| 4005-01/MT25-N | 5 | In distribution | |
| 4000/D98x20-3 | In distribution | ||
| 4003-01B/3-.5 | In distribution | ||
| 4005-JP/LCustom | 5 | In distribution | |
| 4005-01/LT25-N | 5 | In distribution | |
| 4005-01/L22-1 | 5 | In distribution | |
| 4000-01/MF1 | 5 | In distribution | |
| 4005-01/LFN | 5 | In distribution | |
| 4002-JP/S-Custom | 5 | In distribution | |
| 4000-01/MF2 | 5 | In distribution | |
| 4000-01/M3 | 5 | In distribution | |
| 4005-JP/L4 | 5 | In distribution | |
| 4005-01/LNZ25 Custom | 5 | In distribution | |
| 4005-01/LNZ25-4 | 5 | In distribution | |
| 4000/D98x25-3 | In distribution | ||
| 4003-01/B Custom | 5 | In distribution | |
| 4005-01/LNZ25-3 | 5 | In distribution | |
| 4005-01/L22-2 | 5 | In distribution | |
| 4003-01BNX5 | In distribution | ||
| 4002-01/S3 | 5 | In distribution | |
| 4005-01/L1 | 5 | In distribution | |
| 4002-JP/S2 | 5 | In distribution | |
| 4000-01/S Custom | 5 | In distribution | |
| 4005-01/LF3 | 5 | In distribution | |
| 4005-01/L4 | 5 | In distribution | |
| 4005-01/LT25 Custom | 5 | In distribution | |
| 4000/D98x20-N | In distribution | ||
| 4002-01/S4 | 5 | In distribution | |
| 4005-01/L3 | 5 | In distribution | |
| 4005-01/L2 | 5 | In distribution | |
| 4005-01/LNZ25-2 | 5 | In distribution | |
| 4005-01/MT25-4 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vertex-Dental BV | Vertex-Dental B.V. | 760 |
| HI-I® | Fricke International, Inc. | 490 |
| Vitacrilic® | Fricke International, Inc. | 249 |
| Nature-Cryl® | GC America Inc. | 205 |
| Nobilium | Cmp Industries, LLC | 167 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 152 |
| AvaDent | Global Dental Science | 150 |
| Dentorium | Wright Medical Technology, Inc. | 137 |
| Duracetal | The Myerson Company Limited | 136 |
| RE-Fine Bright | Yamahachi Dental MFG. Co. | 134 |
| Axcent Acrylics | Garreco, LLC | 132 |
| Karadent by TCS | Thermoplastic Comfort SYS | 91 |
Showing 12 of 3,288. All products under Resin, Denture, Relining, Repairing, Rebasing
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.