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Klockner
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 10 06 09Model Basic UDI
by Soadco, S.l.
Identity
- Trade Name
- DRILL EXTENSION EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Dental drill bit extension FDA UDI
- Device Name
- DRILL EXTENSION FDA UDI
- Model / Reference
- 10 06 09 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- DRILL EXTENSION FDA UDI
Identifiers
- Catalog Number
- 10 06 09 FDA UDI
- Primary DI / UDI-DI
- 08435451661036 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF13QH EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental drill bit extension 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: Dental drill bit extension
Klockner by Soadco, S.l. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental drill bit extension.
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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 727a67fd-e739-4bf0-bdba-67891ff79f5c 35 fields · synced Jun 18, 2026
- EUDAMED bebfe9cc-f275-4ab0-8381-95c6681677a3 61 fields · synced Jun 18, 2026