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Sign in to claim this brandBiotem Co., ltd
US
Last updated May 25, 2026
What Biotem Co., ltd makes
Biotem Co., Ltd manufactures dental implant systems, including components designed for osseointegration in oral and maxillofacial applications. Their portfolio also includes bone pins, which are used for internal fixation in surgical procedures. The devices are intended for use in dental and orthopedic settings, supporting structural stability and integration with bone tissue.
The company’s products are regulated under the FDA’s classification system, with devices falling into Class I and Class II categories. These are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Biotem Co., Ltd primarily manufacture?
Biotem Co., Ltd specializes in dental implant systems, which are designed to integrate with bone tissue for oral and maxillofacial applications. Their portfolio also includes bone pins, which are used in surgical procedures for internal fixation to stabilize bone structures. These devices are intended for use in both dental and orthopedic settings.
Where is Biotem Co., Ltd based, and how does this affect its regulatory standing?
Biotem Co., Ltd is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the FDA’s system. This ensures compliance with U.S. medical device requirements and traceability through the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries list Biotem Co., Ltd’s devices, and why is this important?
Biotem Co., Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides a standardized way to track and identify medical devices, ensuring transparency, traceability, and compliance with U.S. regulatory requirements for device safety and performance.
How are Biotem Co., Ltd’s devices classified under U.S. regulations, and what does this classification mean?
Biotem Co., Ltd’s devices are classified as either Class I or Class II under the FDA’s regulatory framework. Class I devices generally pose the lowest risk and may require less stringent controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. Classification determines the regulatory pathway and oversight required for each device type.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 557793214
Catalogue (561)
Page 6 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Biotem | FXIR4008 | FDA UDI | Class II | Active |
| Biotem | HAA557M | EUDAMEDFDA UDI | Class II | Active |
| Biotem | SAAT65745 | FDA UDI | Class II | Active |
| Biotem | FD21HL | FDA UDI | Class I | Active |
| Biotem | SAAT45527N | FDA UDI | Class II | Active |
| Bone Cup | BPC08D20 | FDA UDI | Class I | Active |
| Biotem | SAAS55644 | FDA UDI | Class II | Active |
| Biotem | IAT4011S | FDA UDI | Class I | Active |
| Biotem | SAAT45555 | EUDAMEDFDA UDI | Class II | Active |
| Biotem | BTTD34130 | FDA UDI | Class I | Active |
| Biotem | AABT40215 | FDA UDI | Class II | Active |
| Biotem | SABT35447 | EUDAMEDFDA UDI | Class II | Active |
| Biotem | BTTD51115 | FDA UDI | Class I | Active |
| Biotem | FXIR5507 | FDA UDI | Class II | Active |
| Biotem | FXBR3310R | FDA UDI | Class II | Active |
| Biotem | ITB4111T | FDA UDI | Class I | Active |
| Biotem | AAAT55425Q | FDA UDI | Class II | Active |
| Biotem | FXBR4010R | FDA UDI | Class II | Active |
| Biotem | SAAT65737N | FDA UDI | Class II | Active |
| Biotem | IAT6011SN | FDA UDI | Class I | Active |
| Biotem | SAIT40435 | FDA UDI | Class II | Active |
| Biotem | SAITB4846C | FDA UDI | Class II | Active |
| Biotem | BTTD37115 | FDA UDI | Class I | Active |
| Biotem | FDIM29OL | FDA UDI | Class I | Active |
| Biotem | IPA3410N | FDA UDI | Class I | Active |
| Biotem | LAB5015 | FDA UDI | Class I | Active |
| Biotem | FXTR5011R | FDA UDI | Class II | Active |
| Biotem | IAT4014S | FDA UDI | Class I | Active |
| Biotem | SAIS607EW | FDA UDI | Class II | Active |
| Biotem | SAAT30515M | EUDAMEDFDA UDI | Class II | Active |
| Biotem | HAA655S | EUDAMEDFDA UDI | Class II | Active |
| Biotem | FDIH31OS | FDA UDI | Class I | Active |
| Biotem | LAB4015 | FDA UDI | Class I | Active |
| Biotem | CSA2800M | EUDAMEDFDA UDI | Class II | Active |
| Biotem | IPA3413N | FDA UDI | Class I | Active |
| Biotem | LAIS48354 | FDA UDI | Class I | Active |
| Biotem | SAAT55627 | FDA UDI | Class II | Active |
| Biotem | SAIS605EW | FDA UDI | Class II | Active |
| Biotem | SAAS45525 | EUDAMEDFDA UDI | Class II | Active |
| Biotem | SAITB605EW | FDA UDI | Class II | Active |
| Biotem | STFA4008 | FDA UDI | Class II | Active |
| Biotem | SABT40515 | FDA UDI | Class II | Active |
| Biotem | IPI6008EW | FDA UDI | Class I | Active |
| Biotem | FXIR4010M | FDA UDI | Class II | Active |
| Biotem | FXBR3311R | FDA UDI | Class II | Active |
| Biotem | FXIR3511M | FDA UDI | Class II | Active |
| Biotem | SAAT55655N | FDA UDI | Class II | Active |
| Biotem | SAAT45544 | EUDAMEDFDA UDI | Class II | Active |
| Biotem | FXBR4008R | FDA UDI | Class II | Active |
| Biotem | ITB5108T | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Biotem Co., Ltd. Busan · KR FEI 3009611645