Non-Sterile Dental Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Non-Sterile Dental Abutment EUDAMEDDitron Dental FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Multi-Unit Angulated Abutment 17° H2mm EUDAMEDAngulated Multi Unit Abutment Collar H2.0 mm 17° Ang. FDA UDI
- Model / Reference
- Multi-unit straight and angulated abutment EUDAMEDMUA-0217 EUDAMEDFDA UDI
- Description
- Angulated Multi Unit Abutment Collar H2.0 mm 17° Ang. FDA UDI
Identifiers
- Catalog Number
- MUA-0217 FDA UDI
- Primary DI / UDI-DI
- 07290109282817 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290109282817 EUDAMED
- 510(k) Number
- K161497 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Non-Sterile Dental Abutment by Ditron Dental Ltd. is a Multi-Unit Angulated Abutment that offers an innovative solution for dental implant placement, providing a secure and stable fixation for dental implants. With its advanced design and cutting-edge technology, this abutment is ideal for patients seeking high-quality dental care.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290109282817 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ditron Dental Ltd.
- EUDAMED SRN
- IL-MF-000015966
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (2)
- EUDAMED bc1ac12f-6e41-4c1e-9eba-89dacfcbc2ac 61 fields · synced Jul 24, 2026
- FDA UDI b6c00672-d925-4e87-a1a5-cca329bf4793 36 fields · synced May 30, 2026