Identity
- Trade Name
- Cleoid-Discoid EUDAMEDCleoid-Discoid DTS U EUDAMEDLMDental FDA UDI
- Generic Name
- Dental restoration carver, resin FDA UDI
- Device Name
- Restorative dental hand instrument EUDAMEDCleoid-Discoid DTS U, Carver, Restoration FDA UDI
- Model / Reference
- 731-732SI EUDAMED731-732ESTU EUDAMEDFDA UDI
- Description
- Cleoid-Discoid DTS U, Carver, Restoration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311219660 EUDAMED06438311037325 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311RESTO102Y EUDAMED
- Direct Marketing DI
- 06438311219660 EUDAMED06438311037325 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental restoration carver, resin 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
Cleoid-Discoid 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 (3)
- EUDAMED e6a5bd79-9d2c-4935-8e32-f5ba5e515148 61 fields · synced Jul 30, 2026
- EUDAMED 7f636832-5cde-45ba-a2bc-1f79a157c327 61 fields · synced May 16, 2026
- FDA UDI a9d9ebbf-caf3-488b-8850-13fd576f11a6 33 fields · synced May 30, 2026