Identity
- Trade Name
- Scanbox pro - Smile Doctors FDA UDI
- Generic Name
- Dental cheek retractor, professional, reusable FDA UDI
- Device Name
- Phone support + Cheek retractor ScanBoxpro M-L Pack. The kit contains 3 elements: 2 Cheek Retractors: one Medium size (M) and one Large size (L). 1 Phone support. FDA UDI
- Model / Reference
- 001 FDA UDI
- Description
- Phone support + Cheek retractor ScanBoxpro M-L Pack. The kit contains 3 elements: 2 Cheek Retractors: one Medium size (M) and one Large size (L). 1 Phone support. FDA UDI
Identifiers
- Catalog Number
- 1010-001 FDA UDI
- Primary DI / UDI-DI
- 03770021392145 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
Yes
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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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 0929724b-c290-44ed-9fd7-9ff4a28b1683 35 fields · synced Jun 8, 2026