Packer-Modeller IO
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Packer-Modeller IO EUDAMEDLMDental FDA UDI
- Generic Name
- Manual dental burnisher, reusable FDA UDI
- Device Name
- Restorative dental hand instrument EUDAMEDPacker-Modeller IO, Restoration FDA UDI
- Model / Reference
- 482-702SI EUDAMED482-483XSI EUDAMEDFDA UDI482-483SI EUDAMED
- Description
- Packer-Modeller IO, Restoration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311215693 EUDAMED06438311034829 EUDAMEDFDA UDI06438311215648 EUDAMED
- Basic UDI-DI
- 6438311RESTO102Y EUDAMED
- Direct Marketing DI
- 06438311215693 EUDAMED06438311034829 EUDAMED06438311215648 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
Packer-Modeller IO by LM-Instruments Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 (4)
- EUDAMED 162f10d7-12c9-4c42-8c50-23fcf0d549f2 61 fields · synced Aug 5, 2026
- EUDAMED 4d07cfb9-af2a-4e93-ae61-928cd69d0d67 61 fields · synced May 18, 2026
- EUDAMED 26763da5-6f6e-4636-8ccf-fa4108e6fcdb 61 fields · synced May 18, 2026
- FDA UDI d57e5111-8579-4fb4-9cf2-1b8ebfde7118 33 fields · synced May 30, 2026