Medentika
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Medentika EUDAMEDFDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- Scanbody FDA UDI
- Model / Reference
- K 1420-SB EUDAMEDFDA UDIScanbody, Scanpost, Scanbody retention screw EUDAMED
- Description
- Scanbody FDA UDI
Identifiers
- Catalog Number
- K 1420-SB FDA UDI
- Primary DI / UDI-DI
- 04251574866066 EUDAMEDFDA UDI
- Basic UDI-DI
- 42515748SCA004BA EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany 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
Yes
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 implant abutment analog, intraoral-scanning, single-use
Medentika by Medentika GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Medentika GmbH
Sources (2)
- FDA UDI fd64677b-06f5-4482-8251-fce175a761d6 34 fields · synced Oct 8, 2026
- EUDAMED 8527ed26-e09c-4d3d-ae60-0a0ec67f289f 61 fields · synced Oct 8, 2026