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Ball Abutment Retainer
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref BASRRSRef BARR3540Ref BARR3520
Identity
- Trade Name
- Ball Abutment Retainer EUDAMEDBall Abutment EUDAMEDBall Abutment Retainer Set FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Ball Abutment Retainer EUDAMEDBall Abutment EUDAMED
- Model / Reference
- BASRRS EUDAMEDFDA UDIBARR3540 EUDAMEDBARR3520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070219713 EUDAMEDFDA UDI08800070219638 EUDAMED08800070219614 EUDAMED
- Basic UDI-DI
- B-08800070219713 EUDAMEDB-08800070219638 EUDAMEDB-08800070219614 EUDAMED
- 510(k) Number
- K211090 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Ball Abutment Retainer by Izenimplant Co., 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-08800070219713 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Izenimplant Co., Ltd
- EUDAMED SRN
- KR-MF-000026205
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (4)
- EUDAMED 41cf393b-484f-49f8-87a6-d376da4dd8ed 61 fields · synced Sep 18, 2026
- EUDAMED 8dcdcd95-1e64-471f-89ba-d0eb9f98e3d9 61 fields · synced May 18, 2026
- EUDAMED e5e06fdd-9999-4a63-a9ee-ebd751f28b63 61 fields · synced May 18, 2026
- FDA UDI 673735a3-2ab5-4014-a3da-15af6b6691c9 33 fields · synced May 24, 2026