Identity
- Trade Name
- ScanBox pro EUDAMEDFDA UDI
- Generic Name
- Dental cheek retractor, professional, reusable FDA UDI
- Device Name
- ScanBox pro EUDAMEDCheeck Retractor for photo acquisition. ScanBox pro S-M Pack (without boxabox, plastic bag only) -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
- 1014-001 EUDAMED001 FDA UDI
- Description
- Cheeck Retractor for photo acquisition. ScanBox pro S-M Pack (without boxabox, plastic bag only) -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
- 03760405340206 EUDAMEDFDA UDI
- Basic UDI-DI
- 3770021392012A0800062 EUDAMED
- Direct Marketing DI
- 03770021392015 EUDAMED
- FDA Product Code
- EIG FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Dental cheek retractor, professional, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
ScanBox pro by Dental Monitoring SAS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3770021392012A0800062 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dental Monitoring SAS
- EUDAMED SRN
- FR-MF-000032882
Sources (2)
- EUDAMED 398e44a8-4f74-4a78-82f7-9a479a2e5892 61 fields · synced Aug 2, 2026
- FDA UDI 6d523b33-f838-4136-bf46-34add0bc71e8 35 fields · synced May 30, 2026