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Sign in to claim this brandDENTOS Inc.
South Korea·KR-MF-000002156
Last updated May 23, 2026
What DENTOS Inc. makes
DENTOS Inc. manufactures orthodontic devices including metal brackets, archwires, and elastic chains, as well as microimplants for skeletal anchorage, orthodontic springs, and reusable surgical screwdrivers. Their portfolio also covers orthodontic pliers and inter-bracket elastic chains for alignment and retention applications.
The company’s products are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in South Korea.
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 DENTOS Inc. manufacture?
DENTOS Inc. specializes in orthodontic devices, including metal brackets, archwires, and elastic chains for tooth alignment. Their portfolio also includes microimplants like the Absoanchor Microimplant for skeletal anchorage, orthodontic springs, reusable surgical screwdrivers, and tools like orthodontic pliers and inter-bracket elastic chains. These products are designed for dental and orthodontic applications.
Where is DENTOS Inc. based, and what region does it primarily serve?
DENTOS Inc. is headquartered in South Korea. While the company’s primary manufacturing base is in Korea, its devices are intended for global use, including markets like the United States, where they are listed in the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries or databases list DENTOS Inc.’s devices?
DENTOS Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.
How are DENTOS Inc.’s devices classified under FDA regulations?
DENTOS Inc.’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
What distinguishes DENTOS Inc.’s orthodontic microimplants from other devices in its portfolio?
DENTOS Inc.’s microimplants, such as the Absoanchor Microimplant, serve as skeletal anchorage solutions in orthodontics, providing stable fixation points for tooth movement without relying on patient cooperation (e.g., headgear or retainers). Unlike traditional orthodontic devices like brackets or wires, these microimplants are implanted into bone, enabling precise and predictable force application for complex cases like space closure or vertical correction.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- South Korea
- Address
- 41, Seongseo-ro 68-gil, Dalseo-gu, Daegu, Republic of Korea, Daegu, South Korea
- Website
- dentos.co.kr
- —
- —
- [email protected]
- Phone
- +82-53-592-5908
- PRRC Contact
- Jin Hyun Kim
- EUDAMED SRN
- KR-MF-000002156
- FDA FEI Number
- —
- DUNS Number
- 688355973
Catalogue (1446)
Page 25 of 29| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Absoanchor Microimplant | γ-JL1817-12 | FDA UDI | Class II | Active |
| Absoanchor Microimplant | γ-BH1716-12 | FDA UDI | Class II | Active |
| Orthodontic wire | N-19X25-U4 | FDA UDI | Class I | Active |
| Orthodontic wire | S-18X25-L3 | FDA UDI | Class I | Active |
| Orthodontic wire | N-16-U4 | FDA UDI | Class I | Active |
| Absoanchor Microimplant | CH1615-06 | FDA UDI | Class II | Active |
| Orthodontic wire | SR-215X28-EL | FDA UDI | Class I | Active |
| Orthodontic wire | SR-12-TL | FDA UDI | Class I | Active |
| Absoanchor Microimplant | γ-JL1615-06 | FDA UDI | Class II | Active |
| Plier, Orthodontic | Turret-L | FDA UDI | Class I | Active |
| Orthodontic wire | SR-10-TL | FDA UDI | Class I | Active |
| Orthodontic wire | NP-17X22-TL | FDA UDI | Class I | Active |
| Orthodontic wire | NP-215X28-TU | FDA UDI | Class I | Active |
| Orthodontic wire | N-18X25-L3 | FDA UDI | Class I | Active |
| Orthodontic wire | N-17X17-U6 | FDA UDI | Class I | Active |
| Absoanchor Microimplant | γ-GH1615-07 | FDA UDI | Class II | Active |
| Orthodontic wire | N-20-U4 | FDA UDI | Class I | Active |
| Orthodontic wire | ND-14-TU | FDA UDI | Class I | Active |
| Absoanchor Microimplant | γ-JL2018-08 | FDA UDI | Class II | Active |
| Orthodontic wire | S-17X25-L3 | FDA UDI | Class I | Active |
| Absoanchor Microimplant | γ-BH1514-12-L | FDA UDI | Class II | Active |
| Orthodontic wire | NA-RS-U1 | FDA UDI | Class I | Active |
| Absoanchor Microimplant | γ-LH1615-10 | FDA UDI | Class II | Active |
| Absoanchor Microimplant | γ-BH1514-06-L | FDA UDI | Class II | Active |
| Orthodontic wire | S-19X25-L2 | FDA UDI | Class I | Active |
| Orthodontic wire | NA-RE-L6 | FDA UDI | Class I | Active |
| Orthodontic wire | S-215X28-U5 | FDA UDI | Class I | Active |
| Orthodontic wire | SR-17X22-TL | FDA UDI | Class I | Active |
| Orthodontic Bracket | TLB-U | FDA UDI | Class I | Unknown |
| Absoanchor Microimplant | γ-SH2018-07 | FDA UDI | Class II | Active |
| Absoanchor Microimplant | γ-LH1514-07 | FDA UDI | Class II | Active |
| Orthodontic wire | NB-RS-L4 | FDA UDI | Class I | Active |
| Orthodontic Spring | NT25-8H | FDA UDI | Class I | Active |
| Pilot Drill | PD-25-0.9 | EUDAMEDFDA UDI | Class I | Active |
| Orthodontic wire | ND-16-TL | FDA UDI | Class I | Active |
| Plier, Orthodontic | NTDP-S | FDA UDI | Class I | Active |
| Orthodontic Wire | N-10-L2 | FDA UDI | Class I | Active |
| Orthodontic wire | SR-20X25-EL | FDA UDI | Class I | Active |
| Variable Crimpable Hook | VCH-L-3 | FDA UDI | Class I | Active |
| Orthodontic Wire | N-08-U5 | FDA UDI | Class I | Active |
| Plier, Orthodontic | BBP | FDA UDI | Class I | Active |
| Orthodontic wire | SR-17X22-TU | FDA UDI | Class I | Active |
| Orthodontic Wire | N-10-U4 | FDA UDI | Class I | Active |
| Orthodontic wire | S-12-U6 | FDA UDI | Class I | Active |
| Orthodontic wire | NR-18X25-TL | FDA UDI | Class I | Active |
| Orthodontic wire | NS-215X28-OL | FDA UDI | Class I | Active |
| Orthodontic wire | NB-RS-L3 | FDA UDI | Class I | Active |
| Orthodontic wire | NB-RE-L2 | FDA UDI | Class I | Active |
| Orthodontic wire | SL-08-SP | FDA UDI | Class I | Active |
| Orthodontic wire | NP-14X25-TU | FDA UDI | Class I | Active |
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