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Klockner
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 20 02 43Model Basic UDI
by Soadco, S.l.
Identity
- Trade Name
- DRILL Ø2.35MM X 14MM [2 · C4] EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Steel dental bur, reusable FDA UDI
- Device Name
- DRILL Ø2.35MM X 14MM [2 • C4] FDA UDI
- Model / Reference
- Basic UDI EUDAMED20 02 43 EUDAMED20 02 42 FDA UDI
- Description
- DRILL Ø2.35MM X 14MM [2 • C4] FDA UDI
Identifiers
- Catalog Number
- 20 02 43 FDA UDI
- Primary DI / UDI-DI
- 08435451661296 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF13QH EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Steel dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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 ad9563a9-3f37-46f5-b684-657ef2ebfbec 35 fields · synced Jul 9, 2026
- EUDAMED 92c3c3b5-ed6f-4e1e-94ba-3d0f02c6b04b 61 fields · synced Jul 9, 2026