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Burnisher
EUDAMEDFDA UDIClass I (EU MDR)
Ref 31-32SIRef 471-473DDESRef 471-473SI
Identity
- Trade Name
- Burnisher EUDAMEDBurnisher-Plugger 1.5-2.5mm ball-ended EUDAMEDLMDental FDA UDI
- Generic Name
- Manual dental burnisher, reusable FDA UDI
- Device Name
- Restorative dental hand instrument EUDAMEDBurnisher-Plugger 1.5-2.5mmball-ended, Restoration FDA UDI
- Model / Reference
- 31-32SI EUDAMED471-473DDES EUDAMEDFDA UDI471-473SI EUDAMED
- Description
- Burnisher-Plugger 1.5-2.5mmball-ended, Restoration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311212982 EUDAMED06438311215303 EUDAMEDFDA UDI06438311215396 EUDAMED
- Basic UDI-DI
- 6438311RESTO102Y EUDAMED
- Direct Marketing DI
- 06438311212982 EUDAMED06438311215303 EUDAMED06438311215396 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
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
Category: Dental appliance fabrication material, ceramic
Burnisher 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
European Union Active
CE/MDR
United States Pending data
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 2bc7e9ac-c316-46ab-b8a7-91e0368a4c77 61 fields · synced Jul 20, 2026
- EUDAMED e4fc508b-3e35-45ab-b415-5d9d458cd333 61 fields · synced May 18, 2026
- EUDAMED b4fd686e-72b0-4e46-9efb-24dbee8743d0 61 fields · synced May 19, 2026
- FDA UDI cb1b69b0-2b46-4ce8-a125-2c307d607ba2 33 fields · synced May 30, 2026