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Klockner
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 82 11 01 01Model Basic UDI
by Soadco, S.l.
Identity
- Trade Name
- i-S3M SCAN ABUTMENT EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, laboratory FDA UDI
- Device Name
- i-S3M SCAN ABUTMENT FDA UDI
- Model / Reference
- 82 11 01 01 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- i-S3M SCAN ABUTMENT FDA UDI
Identifiers
- Catalog Number
- 82 11 01 01 FDA UDI
- Primary DI / UDI-DI
- 08435451650252 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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 milling system, CAD/CAM, laboratory
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 36b3320f-5bc2-40e2-8ad7-aa0e4ac0be47 35 fields · synced Jul 18, 2026
- EUDAMED 79ddd15c-9b7c-4d5d-8be9-979cbba78cdb 61 fields · synced Jul 18, 2026