Identity
- Trade Name
- HyperByte FDA UDI
- Generic Name
- Orthodontic vibrator FDA UDI
- Device Name
- HyperByte is an orthodontic accessory device intended for use during orthodontic treatment to facilitate minor anterior tooth movement. FDA UDI
- Model / Reference
- ASM-20018-05 FDA UDI
- Description
- HyperByte is an orthodontic accessory device intended for use during orthodontic treatment to facilitate minor anterior tooth movement. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852673007127 FDA UDI
- FDA Product Code
- OYH FDA UDI
- GMDN Term
- Orthodontic vibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic vibrator
HyperByte by Propel Orthodontics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic vibrator.
- Byte — Dentsply International · Class II
- SureSmile — Dentsply International · Class II
- SureSmile — Dentsply International · Class II
- VPro+ — PROPEL ORTHODONTICS LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Propel Orthodontics Llc
Sources (1)
- FDA UDI 1179e4b9-0d51-4244-a849-5965812e449b 34 fields · synced Jun 1, 2026