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Sign in to claim this brandOrtholution Co., Ltd.
US
Last updated May 23, 2026
What Ortholution Co., Ltd. makes
Ortholution Co., Ltd. manufactures orthodontic anchoring screws, including the ORLUS MINI SCREW, designed for use in dental and orthodontic procedures to provide skeletal anchorage during tooth movement or alignment.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. The company is based in 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 Ortholution Co., Ltd. manufacture?
Ortholution Co., Ltd. specializes in orthodontic anchoring screws, such as the ORLUS MINI SCREW. These devices are specifically designed for dental and orthodontic applications to offer skeletal anchorage during procedures like tooth movement or alignment. Their focus is on orthodontic hardware rather than broader medical or surgical tools.
Where is Ortholution Co., Ltd. based, and how does that affect its regulatory standing?
Ortholution Co., Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s classification system determines the level of oversight required for medical devices, and Ortholution’s products fall under Class II, indicating moderate regulatory control. This classification is based on the risk associated with the device’s intended use.
Which regulatory registries list Ortholution Co., Ltd.’s devices, and why are these important?
Ortholution Co., Ltd.’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identifier) registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures accurate identification and tracking of medical devices in the supply chain. These registries help ensure transparency, traceability, and compliance with U.S. regulatory requirements.
How are Ortholution Co., Ltd.’s devices classified under FDA regulations, and what does this mean?
Ortholution Co., Ltd.’s orthodontic anchoring screws, including the ORLUS MINI SCREW, are classified as Class II devices under FDA regulations. This classification is determined by the device’s risk level and intended use. Class II devices require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance, but they do not pose the highest risk associated with Class III devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- 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
- 689964302
Catalogue (96)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Orlus Mini Screw | 1O16113 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H18111 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H16212 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H16109 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O18113 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H16106 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O18309 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H16308 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H16110 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O18207 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O16111 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O16210 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 2O14106 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H16113 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H18108 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O18208 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H18211 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H18206 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O16208 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 2O18208 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O16213 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O16108 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H16213 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O18211 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 2O18107 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 2O16207 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O16109 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O14107 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H16209 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O16308 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H16207 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H18112 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H18309 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H18106 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O18213 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H18113 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1O18110 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 2O16206 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H18209 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H18109 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H16107 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H16105 | FDA UDI | Class II | Active |
| Orlus Mini Screw | 1H14106 | FDA UDI | Class II | Active |
| Modification To: Orlus Mini Screw | K052968 | FDA 510(k) | Class II | Active |
| Orlus Mini Screw | K082838 | FDA 510(k) | Class II | Active |
| Orlus Mini Screw | K050568 | FDA 510(k) | Class II | Active |
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