Identity
- Trade Name
- Explorer, prosthetic DTS EUDAMEDLMDental FDA UDI
- Generic Name
- Dental surgical probe, reusable FDA UDI
- Device Name
- Diagnostic dental hand instrument EUDAMED18-19 Explorer, prosthetic DTS, Diagnostics FDA UDI
- Model / Reference
- 18-19EST EUDAMEDFDA UDI
- Description
- 18-19 Explorer, prosthetic DTS, Diagnostics FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311001661 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311DIAGNO10QV EUDAMED
- Direct Marketing DI
- 06438311001661 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental surgical probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Finland 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Explorer, prosthetic DTS by LM-Instruments Oy — 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 | 6438311DIAGNO10QV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED 14108d4e-19aa-4f39-967e-561bd2f07d9c 61 fields · synced Jul 15, 2026
- FDA UDI 3db3b05a-e9ba-40fd-b218-24b16e7bd8c5 33 fields · synced May 30, 2026