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Sign in to claim this brandWhat Smarter Alloys Inc makes
Smarter Alloys Inc manufactures single-use rotary and reciprocating endodontic files, designed for root canal procedures, and orthodontic archwires for dental alignment. The Paradigm BX and Paradigm Quantum series are among the endodontic files offered, while the SmartArch line includes archwires for braces.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) system. The company 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 Smarter Alloys Inc manufacture?
Smarter Alloys Inc specializes in two primary categories of dental devices: single-use rotary and reciprocating endodontic files (such as the Paradigm BX and Paradigm Quantum series) for root canal treatments, and orthodontic archwires (like the SmartArch line) used in braces for dental alignment. These devices are designed to assist in precise dental procedures.
Where is Smarter Alloys Inc based?
Smarter Alloys Inc is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with US-based medical device standards.
Which regulatory registries list Smarter Alloys Inc’s devices?
Smarter Alloys Inc’s devices are included in the FDA’s Unique Device Identification (UDI) system. This registry helps track and identify medical devices in the US market, ensuring traceability and compliance with regulatory requirements.
How are Smarter Alloys Inc’s devices classified under FDA regulations?
Smarter Alloys Inc’s devices, including endodontic files and orthodontic archwires, are classified as Class I under FDA regulations. This classification applies to low-risk devices that pose minimal potential harm to patients, often requiring only general controls like good manufacturing practices (GMP) for oversight.
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
- 200106716
Catalogue (21)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Paradigm BX | M4 | FDA UDI | Class I | Active |
| Paradigm Quantum | MDHT | FDA UDI | Class I | Active |
| Paradigm BX | A1 | FDA UDI | Class I | Active |
| SmartArch | SAO-DREU-1825 | FDA UDI | Class I | Active |
| Paradigm Quantum | SM | FDA UDI | Class I | Active |
| Paradigm BX | AX | FDA UDI | Class I | Active |
| SmartArch | SAO-DROL-0016 | FDA UDI | Class I | Active |
| Paradigm Quantum | PR | FDA UDI | Class I | Active |
| Paradigm Quantum | PRHT | FDA UDI | Class I | Active |
| Paradigm Quantum | LG | FDA UDI | Class I | Active |
| Paradigm BX | M3 | FDA UDI | Class I | Active |
| Paradigm Quantum | SMHT | FDA UDI | Class I | Active |
| Paradigm BX | M1 | FDA UDI | Class I | Active |
| SmartArch | SAO-DREL-1825 | FDA UDI | Class I | Active |
| Paradigm BX | A2 | FDA UDI | Class I | Active |
| Paradigm BX | M5 | FDA UDI | Class I | Active |
| Paradigm Quantum | MD | FDA UDI | Class I | Active |
| Paradigm Quantum | LGHT | FDA UDI | Class I | Active |
| Paradigm BX | AS | FDA UDI | Class I | Active |
| Paradigm BX | M2 | FDA UDI | Class I | Active |
| SmartArch | SAO-DROU-0016 | FDA UDI | Class I | Active |
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