Identity
- Trade Name
- Endo Plugger 0.5-1.0mm DTS EUDAMEDLMDental FDA UDI
- Generic Name
- Orthodontic ligature director FDA UDI
- Device Name
- Endodontic dental hand instrument EUDAMEDEndo Plugger 0.5-1.0mm DTS, Plugger, Endodontics FDA UDI
- Model / Reference
- 41-42EST EUDAMEDFDA UDI
- Description
- Endo Plugger 0.5-1.0mm DTS, Plugger, Endodontics FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311041414 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311ENDO10PV EUDAMED
- Direct Marketing DI
- 06438311041414 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic ligature director 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
Endo Plugger 0.5-1.0mm DTS 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 | 6438311ENDO10PV | 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 (2)
- EUDAMED 6f691877-e298-41bd-b9e6-1d90424804b8 61 fields · synced Jun 18, 2026
- FDA UDI aaa0372b-8bb3-49c2-9092-42d149b9cf09 33 fields · synced May 30, 2026