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Sign in to claim this brandAURADONICS INC.
US
Last updated May 24, 2026
What AURADONICS INC. makes
Auradonics Inc. manufactures orthodontic accessories, including archwire/bracket ligatures, inter-arch elastic bands, inter-bracket elastic chains, and dental separators. These products are designed for use in braces and aligner treatments to apply controlled forces and maintain spacing between teeth.
The company’s portfolio consists of Class I medical devices, all listed in the FDA’s Unique Device Identification (UDI) system. The products are regulated under U.S. FDA requirements and are 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 Auradonics Inc. manufacture?
Auradonics Inc. specializes in orthodontic accessories, including archwire/bracket ligatures, inter-arch elastic bands, inter-bracket elastic chains, and dental separators. These devices are primarily used in braces and aligner treatments to help apply gentle, controlled forces or maintain proper tooth spacing during orthodontic care.
Where is Auradonics Inc. based, and how does that affect its regulatory oversight?
Auradonics Inc. is based in the United States. Since it operates within the U.S., its devices are subject to FDA regulations. The company’s products are classified as Class I medical devices, which are generally considered low-risk but still require compliance with FDA requirements, including listing in the FDA’s Unique Device Identification (UDI) system.
Are Auradonics Inc.’s devices listed in any regulatory registries, and why does this matter?
Yes, Auradonics Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry helps ensure traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and patients to verify the identity of the device and its manufacturer. Listing in the UDI system is a requirement for Class I devices in the U.S.
How are Auradonics Inc.’s devices classified under FDA regulations, and what does that classification mean?
Auradonics Inc.’s devices are classified as Class I medical devices by the FDA. This classification is assigned based on the risk associated with the device—Class I devices are generally considered the lowest risk, often involving minimal potential harm to the user. While they still require compliance with FDA requirements, such as proper labeling and manufacturing controls, they do not undergo the same rigorous pre-market review as higher-risk devices.
What kinds of orthodontic treatments are Auradonics Inc.’s devices designed to support?
Auradonics Inc.’s devices are designed to support traditional braces and aligner treatments. The archwire/bracket ligatures and elastic chains help secure components of braces, while inter-arch elastic bands and separators apply controlled forces to move teeth or maintain spacing. These accessories are integral to achieving precise orthodontic outcomes during treatment.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- [email protected]
- Phone
- 8567648866
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 608537379
Catalogue (852)
Page 7 of 18| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Auradonics | 811-216 | FDA UDI | Class I | Active |
| Auradonics | 811-158NL | FDA UDI | Class I | Active |
| Phoenix | P-700-517 | FDA UDI | Class I | Active |
| Auradonics | 811-210 | FDA UDI | Class I | Active |
| Auradonics | 811-048 | FDA UDI | Class I | Active |
| Auradonics | 300-117 | FDA UDI | Class I | Active |
| Phoenix | P-700-505 | FDA UDI | Class I | Active |
| Auradonics | 811-009 | FDA UDI | Class I | Active |
| Auradonics | 700-309 15 | FDA UDI | Class I | Active |
| Auradonics | 300-220 | FDA UDI | Class I | Active |
| Auradonics | 811-178NNL | FDA UDI | Class I | Active |
| Auradonics | 811-175 | FDA UDI | Class I | Active |
| Auradonics | 811-007 | FDA UDI | Class I | Active |
| Auradonics | 700-410 15 | FDA UDI | Class I | Active |
| Auradonics | 300-307 | FDA UDI | Class I | Active |
| Auradonics | 700-645 | FDA UDI | Class I | Active |
| Auradonics | 700-427 7.5 | FDA UDI | Class I | Active |
| Auradonics | 300-403 | FDA UDI | Class I | Active |
| Auradonics | 812-002 OSE | FDA UDI | Class I | Active |
| Auradonics | 811-008 | FDA UDI | Class I | Active |
| Auradonics | 811-232NNL | FDA UDI | Class I | Active |
| Auradonics | 811-019NNL | FDA UDI | Class I | Active |
| Auradonics | 300-321 | FDA UDI | Class I | Active |
| Auradonics | 300-213 | FDA UDI | Class I | Active |
| Auradonics | 700-521 15 | FDA UDI | Class I | Active |
| Phoenix | P-300-106 | FDA UDI | Class I | Active |
| Auradonics | 700-512 7.5 | FDA UDI | Class I | Active |
| Auradonics | 300-714 | FDA UDI | Class I | Active |
| Auradonics | 700-509 15 | FDA UDI | Class I | Active |
| Auradonics | 700-415 15 | FDA UDI | Class I | Active |
| Auradonics | 700-322 7.5 | FDA UDI | Class I | Active |
| Auradonics | 811-310 | FDA UDI | Class I | Active |
| Auradonics | 700-431 15 | FDA UDI | Class I | Active |
| Auradonics | 700-519 7.5 | FDA UDI | Class I | Active |
| Auradonics | 300-411 BK | FDA UDI | Class I | Active |
| Auradonics | 811-037NL | FDA UDI | Class I | Active |
| Auradonics | 812-004 OSE | FDA UDI | Class I | Active |
| Auradonics | 700-730T | FDA UDI | Class I | Active |
| Auradonics | 300-723 | FDA UDI | Class I | Active |
| Auradonics | 300-206 | FDA UDI | Class I | Active |
| Auradonics | 300-204 | FDA UDI | Class I | Active |
| Phoenix | P-700-300 | FDA UDI | Class I | Active |
| Phoenix | P-300-301 | FDA UDI | Class I | Active |
| Auradonics | 300-421 | FDA UDI | Class I | Active |
| Auradonics | 300-225 | FDA UDI | Class I | Active |
| Auradonics | 811-021NNL | FDA UDI | Class I | Active |
| Phoenix | P-300-313 | FDA UDI | Class I | Active |
| Auradonics | 300-131 | FDA UDI | Class I | Active |
| Phoenix | P-300-209 | FDA UDI | Class I | Active |
| Phoenix | P-700-308 | FDA UDI | Class I | Active |
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