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GingivalMarginTrimmer1.2mm mesDTS
EUDAMEDFDA UDIClass I (EU MDR)
Ref 125-126ESTModel Dental hand instrument, gingival margin for the finishing of cavity
Identity
- Trade Name
- GingivalMarginTrimmer1.2mm mesDTS EUDAMEDGingivalMarginTrimmer1.2mm mes DTS EUDAMEDLMDental FDA UDI
- Generic Name
- Dental excavator, reusable FDA UDI
- Device Name
- Restorative hand instrument Ir EUDAMEDGingival Margin Trimmer, 1.2mm mesial DTS, Restoration FDA UDI
- Model / Reference
- 125-126EST EUDAMEDFDA UDIDental hand instrument, gingival margin for the finishing of cavity EUDAMED
- Description
- Gingival Margin Trimmer, 1.2mm mesial DTS, Restoration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311202419 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311RESTO1r0C6 EUDAMEDB-06438311202419 EUDAMED
- Direct Marketing DI
- 06438311202419 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L159002 DENTAL EXCAVATORS, REUSABLE EUDAMED
- GMDN Term
- Dental excavator, 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
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
GingivalMarginTrimmer1.2mm mesDTS by LM-Instruments Oy — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438311RESTO1r0C6 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438311RESTO1r0C6 | 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 ce61238c-47a3-49a4-8b41-0b15f47371e6 61 fields · synced Jul 14, 2026
- EUDAMED bfbdbbb8-b89d-4b3c-b706-e687b511bdf4 61 fields · synced May 18, 2026
- FDA UDI 638d6c04-f692-4672-928d-4fac76fc2df8 33 fields · synced May 30, 2026