Klockner
FDA UDIEUDAMEDClass I (US FDA UDI)
by Soadco, S.l.
Identity
- Trade Name
- i-ST 2 SCAN ABUTMENT EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, laboratory FDA UDI
- Device Name
- i-ST 2 SCAN ABUTMENT FDA UDI
- Model / Reference
- 82 21 02 01 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- i-ST 2 SCAN ABUTMENT FDA UDI
Identifiers
- Catalog Number
- 82 21 02 01 FDA UDI
- Primary DI / UDI-DI
- 08435451650658 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF9N1P2 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental milling system, CAD/CAM, laboratory 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
No
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: Dental milling system, CAD/CAM, laboratory
The KLOCKNER i-ST 2 SCAN ABUTMENT is a comprehensive dental milling system designed for precision and accuracy in creating custom-made restorations and orthodontic appliances. Equipped with three-dimensional image acquisition capabilities, software for record collection and treatment planning, and robotic production capabilities, this device enables dental laboratories to produce high-quality devices with ease.
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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 a816ee3e-0ce2-43ae-bad8-dac95a375a95 35 fields · synced Jul 24, 2026
- EUDAMED 13ce0169-ecf0-4831-8c4d-5ae6cb43b5c6 61 fields · synced Jun 19, 2026