← Back to catalogue
Klockner
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 20 02 52Model Basic UDI
by Soadco, S.l.
Identity
- Trade Name
- DRILL Ø3.6MM X 08MM [2 · F1] EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Steel dental bur, reusable FDA UDI
- Device Name
- DRILL Ø3.6MM X 08MM [2 • F1] FDA UDI
- Model / Reference
- Basic UDI EUDAMED20 02 52 EUDAMED20 02 51 FDA UDI
- Description
- DRILL Ø3.6MM X 08MM [2 • F1] FDA UDI
Identifiers
- Catalog Number
- 20 02 52 FDA UDI
- Primary DI / UDI-DI
- 08435451661388 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
Similar devices
Also classified as Steel dental bur, reusable.
- Tru-Fix — ACE SURGICAL SUPPLY CO., INC. · Class I
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- House Brand Dentistry — Frontier Dental Supply Inc · Class I
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- House Brand Dentistry — Frontier Dental Supply Inc · Class I
- House Brand Dentistry — Frontier Dental Supply Inc · Class I
- BUSCH®, BNA® — BUSCH & CO. GmbH & Co. KG · Class I
- House Brand Dentistry — Frontier Dental Supply Inc · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Soadco, S.l.
Sources (2)
- FDA UDI 09a85677-78c6-4dd6-94ad-1c16dcce3e8c 35 fields · synced Jul 9, 2026
- EUDAMED 1a5ab19f-18fe-4ecf-8aeb-e1ca321151cc 61 fields · synced Jul 9, 2026