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DentalMonitoring
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 2001-001Model 003
Identity
- Trade Name
- DentalMonitoring EUDAMEDFDA UDI
- Generic Name
- Patient self-taken medical image communication software FDA UDI
- Device Name
- DentalMonitoring EUDAMEDDental treatment remote monitoring FDA UDI
- Model / Reference
- 003 EUDAMEDFDA UDI2001-001 EUDAMED
- Description
- Dental treatment remote monitoring FDA UDI
Identifiers
- Catalog Number
- 2001-001 FDA UDI
- Primary DI / UDI-DI
- 03770021392114 EUDAMEDFDA UDI
- Basic UDI-DI
- 37700213922001-001VL EUDAMED
- 510(k) Number
- DEN230035 FDA UDI
- FDA Product Code
- SBC FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Patient self-taken medical image communication software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1770 FDA UDI
- Special Device Type
- Software 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
Yes
EUDAMED
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 IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN230035 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 37700213922001-001VL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dental Monitoring SAS
- EUDAMED SRN
- FR-MF-000032882
Sources (3)
- EUDAMED 1b1af3dc-59f4-4351-8fec-7282cdb7fbe0 61 fields · synced Jul 20, 2026
- FDA UDI e5b3d720-122c-44ee-9750-334609fc199c 36 fields · synced May 30, 2026
- FDA 510(k) DEN230035 1 fields · synced May 18, 2026