Identity
- Trade Name
- Brightbyte Pro Refill Pens FDA UDI
- Generic Name
- Teeth whitening kit FDA UDI
- Device Name
- Whitening and Desensitizing Gel Pens FDA UDI
- Model / Reference
- BBPRP FDA UDI
- Description
- Whitening and Desensitizing Gel Pens FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017524118 FDA UDI
- FDA Product Code
- MAU FDA UDI
- GMDN Term
- Teeth whitening kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6855 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Teeth whitening kit
Brightbyte Pro Refill Pens by Straight Smile Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Teeth whitening kit.
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- Classic — NU RADIANCE, INC.
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- Philips Zoom! Chairside Light-Activated Whitening Kit — Discus Dental, Inc. · Class II
- GlorySmile — Jiangxi Dentalbright Technology Co., Ltd · Class I
- Classic — NU RADIANCE, INC.
- Classic — NU RADIANCE, INC.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Straight Smile Llc
Sources (1)
- FDA UDI e0ce1126-9fe8-4431-b63d-89e58bc970be 34 fields · synced Jun 8, 2026