Identity
- Trade Name
- Cord Packer 2.6mm EUDAMEDLMDental FDA UDI
- Generic Name
- Manual dental burnisher, reusable FDA UDI
- Device Name
- Restorative dental hand instrument EUDAMEDCord Packer 2.6mm, Restoration FDA UDI
- Model / Reference
- 492-493XSI EUDAMEDFDA UDI
- Description
- Cord Packer 2.6mm, Restoration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311216041 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311RESTO102Y EUDAMED
- Direct Marketing DI
- 06438311216041 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental appliance fabrication material, ceramic
The Cord Packer 2.6mm is a high-quality, Class I medical device used for instrument handling in restorative dental procedures. Its sterile design ensures effective sterilization and safe use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438311RESTO102Y | 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 3f65fb07-1ca5-4096-bfe5-b5905c4b6f3e 61 fields · synced Jul 25, 2026
- FDA UDI 4e9ec029-9632-4981-87bd-c3988115296a 33 fields · synced May 30, 2026