← Back to catalogue
Non-Sterile Dental Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ABT-6033Model Straight and anatomic abutmentsRef BAL-10010Model Ball AttachmentRef TBCL-8232-25Model Angulated and anatomic abutmentsRef HC-1032Model Healing capRef TBMU-8245
Identity
- Trade Name
- Non-Sterile Dental Abutment EUDAMEDDitron Dental FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Slim Ti Abutment Long Ø3.3mm L8.5mm EUDAMEDBall Attachment Abutment H1mm EUDAMEDTi-Base Cylindrical Non-Engaged H2.5mm EUDAMEDSlim Anatomic Healing Cap H2mm EUDAMEDMulti Unit Ti-Base Non-Engaged EUDAMEDTi-Base Cylindrical Non-Engaged H2.5 FDA UDI
- Model / Reference
- Straight and anatomic abutments EUDAMEDABT-6033 EUDAMEDBall Attachment EUDAMEDBAL-10010 EUDAMEDAngulated and anatomic abutments EUDAMEDTBCL-8232-25 EUDAMEDFDA UDIHealing cap EUDAMEDHC-1032 EUDAMEDTBMU-8245 EUDAMED
- Description
- Ti-Base Cylindrical Non-Engaged H2.5 FDA UDI
Identifiers
- Catalog Number
- TBCL-8232-25 FDA UDI
- Primary DI / UDI-DI
- 07290109283371 EUDAMED07290109283883 EUDAMED07290109283920 EUDAMEDFDA UDI07290109283869 EUDAMED07290109283845 EUDAMED
- Basic UDI-DI
- B-07290109283371 EUDAMEDB-07290109283883 EUDAMEDB-07290109283920 EUDAMEDB-07290109283869 EUDAMEDB-07290109283845 EUDAMED
- 510(k) Number
- K140728 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Non-Sterile Dental Abutment by Ditron Dental Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290109283371 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ditron Dental Ltd.
- EUDAMED SRN
- IL-MF-000015966
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (6)
- EUDAMED eee76a6d-e490-4785-93ae-6b82ca5c85b9 61 fields · synced Jul 31, 2026
- EUDAMED 06f12672-8d77-455c-b049-8b291edd6361 61 fields · synced May 17, 2026
- EUDAMED 65ff8001-ce70-4a36-a571-8843fea9bc05 61 fields · synced May 18, 2026
- EUDAMED 1e1b7b48-d5c1-41f9-a2a6-eaace514968c 61 fields · synced May 18, 2026
- EUDAMED 2e32922f-1f74-42ec-92e4-6b7e1343b2f9 61 fields · synced May 19, 2026
- FDA UDI 12a2341d-b328-48a2-a01b-a23675bf2c87 37 fields · synced May 30, 2026