Biotem
Biotem BR TYPE FIXTURE DRIVER
10manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Hebei (4), Shanghai (3), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
Record
| Listed by | Biotem Co., Ltd., South Korea |
|---|---|
| FDA product code | EIL |
| Device type | Gauge, Depth, Instrument, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FDBH35L | In distribution | |
| FD21RS | In distribution | |
| FDIM29OL | In distribution | |
| FDBM4108C | In distribution | |
| FDBM4112C | In distribution | |
| FD25HL | In distribution | |
| FDBM5008 | In distribution | |
| FDBM3512C | In distribution | |
| FD21RL | In distribution | |
| FD21HS | In distribution | |
| FDIM31OL | In distribution | |
| FD21HL | In distribution | |
| FDBH35S | In distribution | |
| FDBH41S | In distribution | |
| FD25RS | In distribution | |
| FDIH29OS | In distribution | |
| FDIH31OL | In distribution | |
| FDIM31OS | In distribution | |
| FDIH29OL | In distribution | |
| FDIH31OS | In distribution | |
| FD25RL | In distribution | |
| FDBH41L | In distribution | |
| FDBH50L | In distribution | |
| FDBH50S | In distribution | |
| FDIM29OS | In distribution | |
| FD25HS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoring | Jordco, Inc. | 41 |
| Dental Instrument | Cowellmedi Co., Ltd. | 36 |
| Surgical Direct | Surgical Direct, Inc. | 29 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 24 |
| EdgeVerify | US Endodontics, LLC | 24 |
| ACE | Ace Surgical Supply Co., Inc. | 16 |
| devemed | Devemed Gmbh | 13 |
| Genesis | Keystone Dental Inc. | 12 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 12 |
| Reicodent | Devemed Gmbh | 12 |
| ID-Ring | Diadent Group Intl., Inc. | 11 |
| Thermafil Plus | Tulsa Dental Products LLC | 11 |
Showing 12 of 126. All products under Gauge, Depth, Instrument, Dental
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.