Biotone® Plastic 20 Deg. Dentron Posteriors
96 catalogue numbers from 69 U 31M, listed by Dentsply LLC, United States, under Denture, Plastic, Teeth. 26 manufacturers in China are registered for this product code.
26manufacturers in China registered for this device type
96catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (3), Hong Kong (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Fuzhou Delphin BIO-Tech Co., Ltd. | Fuzhou | Fujian | Manufacturer | 18 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Improve Co., Limited | Lantau Island | Hong Kong | Contract manufacturer | 16 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Heyuan HEY White Technology Co., Ltd. | Heyuan | Guangdong | Manufacturer | 12 |
| Beijing Yingguan Dental Science&Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 11 |
| Smile Dental Laboratory Company Limited | Zhuhai | Guangdong | Manufacturer | 11 |
Showing 12 of 26. All 26 manufacturers in China registered for Denture, Plastic, Teeth
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | ELM |
| Device type | Denture, Plastic, Teeth |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3590 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-10-10 |
| Record revised | 2023-12-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2022-05-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 69 U 31M | Withdrawn | |
| 59 U 29M | Withdrawn | |
| 59 L 29M | Withdrawn | |
| 65 U 31M | Withdrawn | |
| 59 U 31M | Withdrawn | |
| 77 L 33L | Withdrawn | |
| 77 U 31M | Withdrawn | |
| 81 U 31M | Withdrawn | |
| 81 L 31L | Withdrawn | |
| 62 L 33M | Withdrawn | |
| 77 L 29M | Withdrawn | |
| 67 L 31M | Withdrawn | |
| 65 U 33M | Withdrawn | |
| 67 U 29L | Withdrawn | |
| 77 U 33L | Withdrawn | |
| 81 L 29M | Withdrawn | |
| 69 L 33M | Withdrawn | |
| 62 U 31M | Withdrawn | |
| 66 L 31L | Withdrawn | |
| 59 U 33L | Withdrawn | |
| 67 U 29M | Withdrawn | |
| 66 L 31M | Withdrawn | |
| 62 U 29L | Withdrawn | |
| 69 U 31L | Withdrawn | |
| 81 U 33M | Withdrawn | |
| 65 L 33L | Withdrawn | |
| 62 L 33L | Withdrawn | |
| 65 U 33L | Withdrawn | |
| 65 L 29M | Withdrawn | |
| 62 U 33L | Withdrawn | |
| 67 L 29L | Withdrawn | |
| 65 L 31L | Withdrawn | |
| 66 L 29M | Withdrawn | |
| 81 L 31M | Withdrawn | |
| 67 L 33M | Withdrawn | |
| 69 L 33L | Withdrawn | |
| 62 L 31M | Withdrawn | |
| 65 U 29M | Withdrawn | |
| 59 L 33L | Withdrawn | |
| 69 L 31L | Withdrawn | |
| 65 U 29L | Withdrawn | |
| 69 U 33L | Withdrawn | |
| 65 L 33M | Withdrawn | |
| 62 U 33M | Withdrawn | |
| 66 U 33M | Withdrawn | |
| 69 U 29M | Withdrawn | |
| 77 L 33M | Withdrawn | |
| 59 L 31M | Withdrawn | |
| 62 L 31L | Withdrawn | |
| 67 L 31L | Withdrawn | |
| 67 L 29M | Withdrawn | |
| 69 L 29L | Withdrawn | |
| 69 U 33M | Withdrawn | |
| 66 L 33L | Withdrawn | |
| 77 L 31M | Withdrawn | |
| 81 L 33L | Withdrawn | |
| 66 U 29M | Withdrawn | |
| 69 L 29M | Withdrawn | |
| 59 L 33M | Withdrawn | |
| 69 L 31M | Withdrawn | |
| 67 U 31L | Withdrawn | |
| 66 U 33L | Withdrawn | |
| 62 L 29M | Withdrawn | |
| 59 U 33M | Withdrawn | |
| 81 U 29L | Withdrawn | |
| 66 U 31M | Withdrawn | |
| 77 L 31L | Withdrawn | |
| 77 U 31L | Withdrawn | |
| 59 L 29L | Withdrawn | |
| 66 U 31L | Withdrawn | |
| 81 U 31L | Withdrawn | |
| 77 U 29M | Withdrawn | |
| 67 U 33M | Withdrawn | |
| 66 L 29L | Withdrawn | |
| 81 U 29M | Withdrawn | |
| 65 U 31L | Withdrawn | |
| 65 L 29L | Withdrawn | |
| 62 U 31L | Withdrawn | |
| 81 U 33L | Withdrawn | |
| 59 U 29L | Withdrawn | |
| 62 U 29M | Withdrawn | |
| 77 U 29L | Withdrawn | |
| 66 U 29L | Withdrawn | |
| 59 U 31L | Withdrawn | |
| 77 L 29L | Withdrawn | |
| 81 L 33M | Withdrawn | |
| 81 L 29L | Withdrawn | |
| 59 L 31L | Withdrawn | |
| 67 L 33L | Withdrawn | |
| 65 L 31M | Withdrawn | |
| 67 U 33L | Withdrawn | |
| 69 U 29L | Withdrawn | |
| 66 L 33M | Withdrawn | |
| 77 U 33M | Withdrawn | |
| 62 L 29L | Withdrawn | |
| 67 U 31M | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resin Teeth DCL PE | Ivoclar Vivadent Aktiengesellschaft | 8,657 |
| Primodent | Polident d.o.o. | 3,814 |
| Resin Teeth S PE S DCL | Ivoclar Vivadent Aktiengesellschaft | 2,870 |
| Vitapan | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2,480 |
| Myerson Special | The Myerson Company Limited | 2,386 |
| Kenson | The Myerson Company Limited | 2,365 |
| Candulor TCR | Candulor, AG | 1,944 |
| Vita Physiodens | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 1,788 |
| Portrait® IPN® Anteriors | Dentsply LLC | 1,674 |
| Enigma Denture Teeth – Pairs | Davis Schottlander & Davis, Ltd. | 1,632 |
| Ivostar Gnathostar | Ivoclar Vivadent Aktiengesellschaft | 1,501 |
| REF-Line | Polident d.o.o. | 1,458 |
Showing 12 of 9,979. All products under Denture, Plastic, Teeth
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K920684 | 1992-12-23 |
| K831214 | 1983-05-09 |
| K792245 | 1980-01-04 |
| K780217 | 1978-03-15 |
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.