Identity
- Trade Name
- Maehlum EUDAMEDMaehlum DTS U EUDAMEDLMDental FDA UDI
- Generic Name
- Dental restoration carver, resin FDA UDI
- Device Name
- Restorative dental hand instrument EUDAMEDMaehlum DTS U, Carver, Restoration FDA UDI
- Model / Reference
- 71-73SI EUDAMED71-73ESTU EUDAMEDFDA UDI
- Description
- Maehlum DTS U, Carver, Restoration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311219615 EUDAMED06438311030715 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311RESTO102Y EUDAMED
- Direct Marketing DI
- 06438311219615 EUDAMED06438311030715 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental restoration carver, resin 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
Maehlum 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 | 6438311RESTO102Y | 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 (3)
- EUDAMED 32bd6bd6-f6c3-449f-a081-2f4bbc617f72 61 fields · synced Jul 21, 2026
- EUDAMED a7e68333-1f41-4b3e-a781-b3e4718668a9 61 fields · synced May 19, 2026
- FDA UDI 7d7a62b8-573d-497c-a657-257b4e2f9af3 33 fields · synced May 30, 2026