Identity
- Trade Name
- ScanBox pro Smile doctors FDA UDI
- Generic Name
- Dental cheek retractor, professional, reusable FDA UDI
- Device Name
- Phone support + Cheek retractor tube ScanBoxpro S-M Pack (without box a box).The kit contains 4 elements: 2 Cheek Retractors: one Small size (S) and one Medium size (M). 1 Adapter. 1 Phone support. FDA UDI
- Model / Reference
- 001 FDA UDI
- Description
- Phone support + Cheek retractor tube ScanBoxpro S-M Pack (without box a box).The kit contains 4 elements: 2 Cheek Retractors: one Small size (S) and one Medium size (M). 1 Adapter. 1 Phone support. FDA UDI
Identifiers
- Catalog Number
- 1014-001 FDA UDI
- Primary DI / UDI-DI
- 03760405340145 FDA UDI
- FDA Product Code
- EIG FDA UDI
- GMDN Term
- Dental cheek retractor, professional, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental cheek retractor, professional, reusableDental cheek retractor, home-use
ScanBox pro Smile doctors by Dental Monitoring — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ScanBox pro Smile Doctors — Dental Monitoring · Class I
- Scanbox pro - Smile Doctors — Dental Monitoring · Class I
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
- Dental Monitoring
Sources (1)
- FDA UDI 305e7134-1c86-47d8-aeb6-0cb779ef6720 35 fields · synced Jun 6, 2026