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Non-Sterile Dental Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref SRA-8131Model Plastic sleeve setModel Overdenture Processing Components
Identity
- Trade Name
- Non-Sterile Dental Abutment EUDAMEDCasting Abutment EUDAMEDDitron Dental FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Burn-Out Plastic Sleeve for Multi-unit Abutment EUDAMEDPlastic Disk for Ball Attachment EUDAMEDBurn-Out Plastic Sleeve for Multi-unit Abutment. FDA UDI
- Model / Reference
- Plastic sleeve set EUDAMEDSRA-8131 EUDAMEDFDA UDIOverdenture Processing Components EUDAMED
- Description
- Burn-Out Plastic Sleeve for Multi-unit Abutment. FDA UDI
Identifiers
- Catalog Number
- SRA-8131 FDA UDI
- Primary DI / UDI-DI
- 07290109283180 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290109283180 EUDAMED729010928ACCE9E EUDAMED
- Direct Marketing DI
- 07290109283180 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMEDQ010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass 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
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
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 — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07290109283180 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-07290109283180 | 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 (3)
- EUDAMED bc3205b2-2b5e-46c3-8f86-92a42feb53c9 61 fields · synced Jul 28, 2026
- FDA UDI 46edfb07-bf90-422f-823e-bf362cf7669c 35 fields · synced May 30, 2026
- EUDAMED a08026a6-ec00-481e-a37f-fcfed4dcd5c3 61 fields · synced Jul 28, 2026