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Klockner
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref KR 003Model Basic UDI
by Soadco, S.l.
Identity
- Trade Name
- MANUAL REVERSING DRILL EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Steel dental bur, reusable FDA UDI
- Device Name
- MANUAL REVERSING DRILL FDA UDI
- Model / Reference
- KR 003 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- MANUAL REVERSING DRILL FDA UDI
Identifiers
- Catalog Number
- KR 003 FDA UDI
- Primary DI / UDI-DI
- 08435451660473 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF20QE EUDAMED
- FDA Product Code
- OFY FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Steel dental bur, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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: Steel dental bur, reusable
Klockner by Soadco, S.l. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Soadco, S.l.
Sources (2)
- FDA UDI ff8532e0-e229-4502-9a3f-381b9fb7c4c5 35 fields · synced Jun 18, 2026
- EUDAMED 087e0621-ae0a-492c-86a7-2344f66404cf 61 fields · synced Jun 18, 2026