Identity
- Trade Name
- DentalMonitoring EUDAMEDDentalMonitoring - Straumann EUDAMEDFDA UDI
- Generic Name
- Patient self-taken medical image communication software FDA UDI
- Device Name
- DentalMonitoring EUDAMEDDental treatment remote monitoring FDA UDI
- Model / Reference
- 2001-001 EUDAMED003 EUDAMEDFDA UDI
- Description
- Dental treatment remote monitoring FDA UDI
Identifiers
- Catalog Number
- 2001-001 FDA UDI
- Primary DI / UDI-DI
- D-37700213924V EUDAMED03760405340251 EUDAMEDFDA UDI03760405340404 EUDAMED
- Basic UDI-DI
- B-37700213924V EUDAMED37700213922001-001VL EUDAMED
- 510(k) Number
- DEN230035 FDA UDI
- FDA Product Code
- SBC FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMEDQ010499,Q0199 EUDAMED
- GMDN Term
- Patient self-taken medical image communication software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1770 FDA UDI
- Special Device Type
- -1192 EUDAMEDSoftware EUDAMED
- 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
DentalMonitoring by Dental Monitoring SAS — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-37700213924V | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-37700213924V | 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 (4)
- EUDAMED cbf4038a-ae3d-4cc6-8d47-9f76ebcdbd0f 61 fields · synced Jul 18, 2026
- EUDAMED 8c75cf94-5253-4850-ab6a-0cda7e07ba74 61 fields · synced May 18, 2026
- EUDAMED 2eb40def-3154-4671-a757-c513373ab97b 61 fields · synced May 19, 2026
- FDA UDI 12ae3763-4b93-4a87-91be-a568488444c2 36 fields · synced May 30, 2026