Klockner
FDA UDIEUDAMEDClass I (US FDA UDI)
by Soadco, S.l.
Identity
- Trade Name
- BONE EXPANDER [WHITE] EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- BONE EXPANDER [WHITE] FDA UDI
- Model / Reference
- 10 04 01 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- BONE EXPANDER [WHITE] FDA UDI
Identifiers
- Catalog Number
- 10 04 01 FDA UDI
- Primary DI / UDI-DI
- 08435451644152 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF18QT EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Fixture/appliance dental drill bit, reusable
Klockner by Soadco, S.l. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 b10b04f6-6916-4ab0-bffb-1efc17465020 35 fields · synced Jun 18, 2026
- EUDAMED 0f11a95c-c205-4c7d-959e-46b213047ee3 61 fields · synced Jun 18, 2026