← Back to catalogue
Implant Misura MR3.1-5.3 DTS U
EUDAMEDFDA UDIClass I (EU MDR)
Ref 402-403ESTUModel Dental hand instrument for implant insertion
Identity
- Trade Name
- Implant Misura MR3.1-5.3 DTS U EUDAMEDLMDental FDA UDI
- Generic Name
- Manual dental burnisher, reusable FDA UDI
- Device Name
- Implant Misura MR3.1-5.3 DTS U, Implant surgery FDA UDI
- Model / Reference
- Dental hand instrument for implant insertion EUDAMED402-403ESTU EUDAMEDFDA UDI
- Description
- Implant Misura MR3.1-5.3 DTS U, Implant surgery FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311213941 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438311213941 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L159003 DENTAL AND PERIODONTAL PROBES AND EXPLORERS, REUSABLE EUDAMED
- GMDN Term
- Manual dental burnisher, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Implant Misura MR3.1-5.3 DTS U by LM-Instruments Oy — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438311213941 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED c3c1a824-aac2-45dc-b28b-70c75930b3b2 61 fields · synced Jul 22, 2026
- FDA UDI d8127d37-175d-45ab-84ea-150a55e2b36e 34 fields · synced May 30, 2026