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Sign in to claim this brandWhat MCT Bio makes
MCT Bio manufactures reusable dental drill bits, manual cranial rotary handpieces, and motorless components for dental power tools. These products include specialized drill bits for dental fixtures and appliances, as well as handpieces designed for cranial surgical applications. The portfolio also covers interchangeable components for dental power tools, ensuring compatibility with existing systems.
The company’s devices are classified as Class I under regulatory standards, with all products listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in dental and surgical settings within 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 MCT Bio manufacture?
MCT Bio specializes in reusable dental and surgical devices. Their portfolio includes dental drill bits for fixtures and appliances, manual cranial rotary handpieces (used in surgical applications), and motorless components designed to fit dental power tools. These products are engineered for precision in dental procedures and cranial surgeries, ensuring compatibility with existing systems.
Where is MCT Bio based, and what regulatory region does it serve?
MCT Bio is based in the United States. Their devices are intended for use within the U.S. regulatory environment, where they are classified under FDA standards. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their compliance with U.S. medical device regulations.
How are MCT Bio’s devices classified under regulatory standards?
All of MCT Bio’s devices fall under Class I classification, which is the lowest risk category for medical devices under regulatory frameworks. This classification applies to their reusable dental drill bits, manual cranial rotary handpieces, and motorless dental power tool components, indicating they pose minimal risk and typically require fewer regulatory controls.
Which regulatory registries or databases list MCT Bio’s devices?
MCT Bio’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to verify the identity and regulatory status of the company’s products. The UDI system is a key requirement for medical devices in the U.S.
What distinguishes MCT Bio’s dental power tool components from other manufacturers?
MCT Bio’s dental power tool components are designed as motorless interchangeable parts, ensuring compatibility with existing dental power tool systems. Unlike full handpiece units, these components focus on modularity, allowing dental professionals to upgrade or replace specific parts without replacing the entire tool. This approach supports efficiency and cost-effectiveness in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- mctbio.com
- —
- —
- [email protected]
- Phone
- +82313337373
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 694484789
Catalogue (40)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Srd-02 | SRD-02 | FDA UDI | Class I | Active |
| Srg-Nan | SRG-NAN | FDA UDI | Class I | Active |
| Srt-02 | SRT-02 | FDA UDI | Class I | Active |
| Srg-3ir | SRG-3IR | FDA UDI | Class I | Active |
| Srd-01 | SRD-01 | FDA UDI | Class I | Active |
| Bec-3.4 | BEC-3.4 | FDA UDI | Class I | Active |
| Frt-4.7/5.4 | FRT-4.7/5.4 | FDA UDI | Class I | Active |
| Frd-02 | FRD-02 | FDA UDI | Class I | Active |
| Frt-5.2/5.9 | FRT-5.2/5.9 | FDA UDI | Class I | Active |
| Srg-Ntn | SRG-NTN | FDA UDI | Class I | Active |
| Srg-Io | SRG-IO | FDA UDI | Class I | Active |
| Bec-2.6 | BEC-2.6 | FDA UDI | Class I | Active |
| Srg-H | SRG-H | FDA UDI | Class I | Active |
| Frt-3.7/4.4 | FRT-3.7/4.4 | FDA UDI | Class I | Active |
| Frt-6.2/6.9 | FRT-6.2/6.9 | FDA UDI | Class I | Active |
| Srg-Ntw | SRG-NTW | FDA UDI | Class I | Active |
| Srg-Er | SRG-ER | FDA UDI | Class I | Active |
| Srg-Sh | SRG-SH | FDA UDI | Class I | Active |
| Frt-3.9/4.6 | FRT-3.9/4.6 | FDA UDI | Class I | Active |
| Srg-Blrp | SRG-BLRP | FDA UDI | Class I | Active |
| Srg-Tsv 5.7 | SRG-TSV 5.7 | FDA UDI | Class I | Active |
| Bec-4.3 | BEC-4.3 | FDA UDI | Class I | Active |
| Srg-Tsv 3.7/4.7 | SRG-TSV 3.7/4.7 | FDA UDI | Class I | Active |
| Srg-Blnp | SRG-BLNP | FDA UDI | Class I | Active |
| Srg-Ntr | SRG-NTR | FDA UDI | Class I | Active |
| Frd-01 | FRD-01 | FDA UDI | Class I | Active |
| Frt-4.3/5.0 | FRT-4.3/5.0 | FDA UDI | Class I | Active |
| Bec-3.0 | BEC-3.0 | FDA UDI | Class I | Active |
| Frd-03 | FRD-03 | FDA UDI | Class I | Active |
| Frt-5.7/6.4 | FRT-5.7/6.4 | FDA UDI | Class I | Active |
| Adapter-H | Adapter-H | FDA UDI | Class I | Active |
| Srg-3in | SRG-3IN | FDA UDI | Class I | Active |
| Adapter-1 | Adapter-1 | FDA UDI | Class I | Active |
| Srg-Nan | SRG-NAN | FDA UDI | Class I | Active |
| Pld-1.8 | PLD-1.8 | FDA UDI | Class I | Active |
| Adapter-A | Adapter-A | FDA UDI | Class I | Active |
| Sra-01 | SRA-01 | FDA UDI | Class I | Active |
| Frw-01 | FRW-01 | FDA UDI | Class I | Active |
| Srt-01 | SRT-01 | FDA UDI | Class I | Active |
| Bec-3.8 | BEC-3.8 | FDA UDI | Class I | Active |
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