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Sign in to claim this brandPROPEL ORTHODONTICS LLC
US
Last updated May 30, 2026
What PROPEL ORTHODONTICS LLC makes
The company manufactures single-use surgical drill guides and orthodontic vibrators designed to assist in dental procedures. Their products include devices like the VPro+ and HyperByte, which are used for orthodontic acceleration and bone preparation in orthodontic treatments.
These devices are regulated under FDA classifications, with some falling under Class I and others under Class II. They are listed in the FDA’s 510(k) and UDI registries, and 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 Propel Orthodontics LLC manufacture?
Propel Orthodontics LLC specializes in two primary categories of devices: single-use surgical drill guides and orthodontic vibrators. These tools are specifically designed to aid in orthodontic treatments, such as bone preparation and acceleration of tooth movement. Examples include devices like the VPro+ and HyperByte, which are tailored for precise and efficient dental procedures.
Where is Propel Orthodontics LLC based?
Propel Orthodontics LLC is headquartered in the United States. The company’s location influences its regulatory compliance, as it must adhere to FDA requirements for devices marketed in the US.
Which regulatory registries list Propel Orthodontics LLC’s devices?
Propel Orthodontics LLC’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for devices classified under FDA regulations.
How are Propel Orthodontics LLC’s devices classified under FDA regulations?
Propel Orthodontics LLC’s devices are classified under two FDA categories: Class I and Class II. The classification depends on the device’s risk level and intended use. For example, some orthodontic vibrators may fall under Class II due to their role in accelerating bone remodeling, while simpler single-use surgical guides could qualify as Class I due to lower risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- propelortho.com
- —
- —
- [email protected]
- Phone
- 408 394 5851
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 117334253
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Propel | ASM-20018 | FDA UDI | Class I | Unknown |
| Acceledent Optima | ASM-20031 | FDA UDI | Class II | Unknown |
| VPro+ | ASM-20023 | FDA UDI | Class II | Active |
| VPro | ASM-20018 | FDA UDI | Class II | Unknown |
| Propel | ASM-20010 | FDA UDI | Class II | Unknown |
| Propel | ASM-20021 | FDA UDI | Class II | Unknown |
| Propel | ASM-20022 | FDA UDI | Class I | Unknown |
| Propel | ASM-20010-01 | FDA UDI | Class II | Active |
| Propel | ASM-20023 | FDA UDI | Class I | Unknown |
| Propel | ASM-20010-03 | FDA UDI | Class I | Active |
| Propel | ASM-20018-04 | FDA UDI | Class I | Unknown |
| Propel | ASM-20010-04 | FDA UDI | Class II | Active |
| Propel | ASM-20010-02 | FDA UDI | Class II | Active |
| HyperByte | ASM-20018-05 | FDA UDI | Class II | Active |
| VPro5 | K183018 | FDA 510(k) | Class II | Active |
| PROPEL device | K150392 | FDA 510(k) | Class II | Active |
| PROPEL Device | K172164 | FDA 510(k) | Class II | Active |
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