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Spoon Excavator 1.0mm DTS U
EUDAMEDFDA UDIClass I (EU MDR)
Ref 522-523ESTUModel Dental hand instrument, excavator for the removal of softened carious dentin
Identity
- Trade Name
- Spoon Excavator 1.0mm DTS U EUDAMEDLMDental FDA UDI
- Generic Name
- Dental excavator, reusable FDA UDI
- Device Name
- Restorative hand instrument Ir EUDAMEDSpoon Excavator 1.0mm DTS U, Restoration FDA UDI
- Model / Reference
- Dental hand instrument, excavator for the removal of softened carious dentin EUDAMED522-523ESTU EUDAMEDFDA UDI
- Description
- Spoon Excavator 1.0mm DTS U, Restoration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311035321 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438311035321 EUDAMED6438311RESTO1r0C6 EUDAMED
- Direct Marketing DI
- 06438311035321 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
Spoon Excavator 1.0mm DTS U by LM-Instruments Oy — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438311035321 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438311035321 | 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 215ec24e-4dd3-4616-bacc-f6175747c7aa 61 fields · synced Jul 8, 2026
- EUDAMED a976fa07-2e1b-43be-a094-efec326f8aee 61 fields · synced May 17, 2026
- FDA UDI a46ed103-5aa8-4357-ab04-fe569b97bcd6 33 fields · synced May 30, 2026