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Sign in to claim this brandOrtho Source
US
Last updated May 23, 2026
What Ortho Source makes
Ortho Source manufactures orthodontic accessories, including stainless steel and nickel-titanium orthodontic wires, orthodontic pliers for bracket placement and wire manipulation, self-removable palate expanders and aligners, two-piece endosteal dental implants with screw fixation, and orthodontic archwires. The company also provides dental etching solutions for bracket bonding and orthodontic bracket adhesives designed for clinical use.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. 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 Ortho Source manufacture?
Ortho Source specializes in orthodontic devices, including stainless steel and nickel-titanium orthodontic wires, orthodontic pliers for bracket placement and wire adjustments, self-removable palate expanders and aligners, two-piece endosteal dental implants with screw fixation, dental etching solutions for bracket bonding, and orthodontic bracket adhesives. These products are designed to support orthodontic treatment and dental restoration procedures.
Where is Ortho Source based, and how does that affect its regulatory compliance?
Ortho Source is based in the United States, which means its devices are subject to FDA regulations. The company’s products are classified under FDA categories, including Class I (generally low-risk devices) and Class II (devices requiring special controls to ensure safety and effectiveness). Since the company operates within the US, its devices must comply with FDA requirements, including UDI labeling and registration.
Are Ortho Source’s devices listed in any regulatory registries, and why does that matter?
Yes, Ortho Source’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because UDI registration ensures traceability, transparency, and compliance with FDA tracking requirements. It allows healthcare providers, regulators, and patients to quickly identify and verify the specific devices in use, reducing risks associated with counterfeit or mislabeled products.
How are Ortho Source’s devices classified under FDA regulations, and what does that classification mean?
Ortho Source’s devices are classified as either Class I or Class II under FDA regulations. Class I devices are typically low-risk items like some orthodontic accessories, requiring general controls to ensure safety. Class II devices, such as certain orthodontic implants or specialized tools, require additional performance standards or post-market surveillance to mitigate moderate risks. Classification determines the regulatory pathway and oversight required for each device.
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
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Catalogue (633)
Page 12 of 13| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Orthosource | 628-718 | FDA UDI | Class I | Active |
| Orthosource | 618-072 | FDA UDI | Class I | Active |
| Orthosource | 615-202 | FDA UDI | Class I | Active |
| Orthosource | 638-079 | FDA UDI | Class I | Active |
| Orthosource | 4015/3 | FDA UDI | Class I | Active |
| Orthosource | 871-139 | FDA UDI | Class I | Unknown |
| Orthosource | 3005/14 | FDA UDI | Class I | Active |
| Orthosource | 618-078 | FDA UDI | Class I | Active |
| Orthosource | 1110C-10 | FDA UDI | Class I | Active |
| Orthosource | PBC-5.0-10 | FDA UDI | Class II | Active |
| Orthosource | 1003K-10 | FDA UDI | Class I | Active |
| Orthosource | 3LT-5.0-8 | FDA UDI | Class II | Active |
| Orthosource | 635-226 | FDA UDI | Class I | Active |
| Orthosource | 615-504 | FDA UDI | Class I | Active |
| Orthosource | 3021 ZS | FDA UDI | Class I | Active |
| Orthosource | 873-140-A | FDA UDI | Class I | Active |
| Orthosource | 618-118W-100 | FDA UDI | Class I | Unknown |
| Orthosource | 618-020 | FDA UDI | Class I | Active |
| Orthosource | 618-082 | FDA UDI | Class I | Active |
| Orthosource | 615-226 | FDA UDI | Class I | Unknown |
| Orthosource | 618-120W | FDA UDI | Class I | Unknown |
| Orthosource | TST-3.3-10 | FDA UDI | Class II | Active |
| Orthosource | 1040 ZG | FDA UDI | Class I | Active |
| Orthosource | 810-008 | FDA UDI | Class I | Active |
| Orthosource | 713-073 | FDA UDI | Class I | Active |
| Orthosource | 618-120W-100 | FDA UDI | Class I | Unknown |
| Orthosource | 618-312W-100 | FDA UDI | Class I | Unknown |
| Orthosource | 1009 LS | FDA UDI | Class I | Unknown |
| Orthosource | 3LT-3.5-10 | FDA UDI | Class II | Active |
| Orthosource | 628-514 | FDA UDI | Class I | Active |
| Orthosource | BC-5.0-13 | FDA UDI | Class II | Active |
| Orthosource | 873-110 | FDA UDI | Class I | Active |
| Orthosource | 618-716W-100 | FDA UDI | Class I | Unknown |
| Orthosource | 635-103 | FDA UDI | Class I | Active |
| Orthosource | 557-863 | FDA UDI | Class II | Active |
| Orthosource | PBC-3.5-13 | FDA UDI | Class II | Active |
| Orthosource | 618-204 | FDA UDI | Class I | Active |
| Orthosource | 871-140 | FDA UDI | Class I | Unknown |
| Orthosource | 615-602 | FDA UDI | Class I | Active |
| Orthosource | 618-021W | FDA UDI | Class I | Active |
| Orthosource | 615-104 | FDA UDI | Class I | Active |
| Orthosource | 615-018 | FDA UDI | Class I | Unknown |
| Orthosource | 614-036 | FDA UDI | Class I | Unknown |
| Orthosource | 4009 G | FDA UDI | Class I | Active |
| Orthosource | 873-108-T | FDA UDI | Class I | Active |
| Orthosource | 618-518 | FDA UDI | Class I | Active |
| Orthosource | 618-320 | FDA UDI | Class I | Unknown |
| Orthosource | 635-105 | FDA UDI | Class I | Active |
| Orthosource | 3LT-5.0-16 | FDA UDI | Class II | Active |
| Orthosource | 635-223 | FDA UDI | Class I | Unknown |
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