Identity
- Trade Name
- DentalMonitoring - Smile Doctors FDA UDI
- Generic Name
- Patient self-taken medical image communication software FDA UDI
- Device Name
- Dental treatment remote monitoring FDA UDI
- Model / Reference
- 003 FDA UDI
- Description
- Dental treatment remote monitoring FDA UDI
Identifiers
- Catalog Number
- 2001-001 FDA UDI
- Primary DI / UDI-DI
- 03760405340237 FDA UDI
- 510(k) Number
- DEN230035 FDA UDI
- FDA Product Code
- SBC FDA UDI
- GMDN Term
- Patient self-taken medical image communication software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1770 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
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
Category: Clinical management support softwarePatient self-taken medical image communication software
DentalMonitoring - Smile Doctors by Dental Monitoring — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient self-taken medical image communication software.
- DentalMonitoring - Candid — Dental Monitoring · Class II
Cleared under the same submission
DEN230035 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Dental Monitoring
Sources (1)
- FDA UDI c7da3801-5b93-497a-b8f0-1c88840b5e59 36 fields · synced May 30, 2026