Identity
- Trade Name
- ScanBox pro EUDAMEDFDA UDI
- Generic Name
- Dental cheek retractor, home-use FDA UDI
- Device Name
- ScanBox pro EUDAMEDCheeck Retractor for photo acquisition. ScanBox pro 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
- 1010-001 EUDAMED001 FDA UDI
- Description
- Cheeck Retractor for photo acquisition. ScanBox pro 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
- 03770021392084 EUDAMEDFDA UDI
- Basic UDI-DI
- 3770021392012A0800062 EUDAMED
- Direct Marketing DI
- 03770021392022 EUDAMED
- FDA Product Code
- EIG FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Dental cheek retractor, home-use 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
Yes
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 8fb71a12-61d0-4a0e-8823-29a98df09945 61 fields · synced Jun 1, 2026
- FDA UDI afe957f9-f663-4828-901f-739f7190797f 35 fields · synced May 30, 2026