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Round Excavator 1.0mm DTS
EUDAMEDFDA UDIClass I (EU MDR)
Ref 61-62ESTModel Dental hand instrument, excavator for the removal of softened carious dentin
Identity
- Trade Name
- Round Excavator 1.0mm DTS EUDAMEDLMDental FDA UDI
- Generic Name
- Dental excavator, reusable FDA UDI
- Device Name
- Restorative hand instrument Ir EUDAMEDRound Excavator 1.0mm DTS, Restoration FDA UDI
- Model / Reference
- 61-62EST EUDAMEDFDA UDIDental hand instrument, excavator for the removal of softened carious dentin EUDAMED
- Description
- Round Excavator 1.0mm DTS, Restoration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311030616 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311RESTO1r0C6 EUDAMEDB-06438311030616 EUDAMED
- Direct Marketing DI
- 06438311030616 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
Round Excavator 1.0mm DTS 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 abcbb911-15cc-466b-bb5a-b2d51ccf83fb 61 fields · synced Jul 19, 2026
- EUDAMED c0f255cc-9294-4ca3-b482-6b9678442c49 61 fields · synced May 17, 2026
- FDA UDI 35e7a25e-88b3-43e7-a435-d5955473450f 33 fields · synced May 30, 2026