← Back to catalogue
Multi Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref MSARR4815SRef MAARRN481745Ref MAARRH481745Ref MSARR4835SRef MAARRN483035Ref MSARR4835Ref MAARRN481735SRef MAARRH481735SRef MAARRH481745SRef MAARRH483045Ref MSARR4825SRef MAARRN481745SRef MAASRH483065Ref MAARRN481735Ref MSARR4845Ref MSARR4825Ref MSARR4815Ref MAARRH483035SRef MAARRH481725S
Identity
- Trade Name
- Multi Abutment EUDAMEDMulti Angled Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Multi Abutment EUDAMEDMulti Abutment (Multi Angled Abutment) EUDAMED
- Model / Reference
- MSARR4815S EUDAMEDMAARRN481745 EUDAMEDMAARRH481745 EUDAMEDMSARR4835S EUDAMEDMAARRN483035 EUDAMEDMSARR4835 EUDAMEDMAARRN481735S EUDAMEDMAARRH481735S EUDAMEDMAARRH481745S EUDAMEDMAARRH483045 EUDAMEDMSARR4825S EUDAMEDMAARRN481745S EUDAMEDMAASRH483065 EUDAMEDFDA UDIMAARRN481735 EUDAMEDMSARR4845 EUDAMEDMSARR4825 EUDAMEDMSARR4815 EUDAMEDMAARRH483035S EUDAMEDMAARRH481725S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070222805 EUDAMED08800070222591 EUDAMED08800070222546 EUDAMED08800070222829 EUDAMED08800070222607 EUDAMED08800070222225 EUDAMED08800070223161 EUDAMED08800070223130 EUDAMED08800070223147 EUDAMED08800070222560 EUDAMED08800070222812 EUDAMED08800070223178 EUDAMED08800070222317 EUDAMEDFDA UDI08800070222584 EUDAMED08800070222232 EUDAMED08800070222218 EUDAMED08800070222201 EUDAMED08800070223185 EUDAMED08800070223123 EUDAMED
- Basic UDI-DI
- B-08800070222805 EUDAMEDB-08800070222591 EUDAMEDB-08800070222546 EUDAMEDB-08800070222829 EUDAMEDB-08800070222607 EUDAMEDB-08800070222225 EUDAMEDB-08800070223161 EUDAMEDB-08800070223130 EUDAMEDB-08800070223147 EUDAMEDB-08800070222560 EUDAMEDB-08800070222812 EUDAMEDB-08800070223178 EUDAMEDB-08800070222317 EUDAMEDB-08800070222584 EUDAMEDB-08800070222232 EUDAMEDB-08800070222218 EUDAMEDB-08800070222201 EUDAMEDB-08800070223185 EUDAMEDB-08800070223123 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 UDIEUDAMED
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
Multi Abutment 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-08800070222805 | 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
- Izenimplant Co., Ltd
- EUDAMED SRN
- KR-MF-000026205
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (20)
- EUDAMED 52465ffa-2f39-4aab-a752-162a421a8767 61 fields · synced Sep 18, 2026
- EUDAMED ccf57572-60ac-4e7a-ae0a-c926c9e584f3 61 fields · synced May 11, 2026
- EUDAMED d47011bf-de79-410c-a5f1-016ef11a2231 61 fields · synced May 16, 2026
- EUDAMED 3cbe6b9b-5b20-412a-8dbe-a7383ce53c19 61 fields · synced May 16, 2026
- EUDAMED 3c98be97-a12c-4beb-a07f-718333ea26bc 61 fields · synced May 16, 2026
- EUDAMED 88c0d90c-d616-4072-9076-5ea633e11914 61 fields · synced May 16, 2026
- EUDAMED a0c7954a-f3eb-4a6d-bea5-06c7f3f75601 61 fields · synced May 17, 2026
- EUDAMED 920aa934-6ee3-41c9-8f9e-e67348e3c9db 61 fields · synced May 17, 2026
- EUDAMED a85cb797-d9ba-4c93-b0a9-e6eec6822ea3 61 fields · synced May 17, 2026
- EUDAMED 1b4dc2df-9ae4-4a89-97ed-ee70f3093dc7 61 fields · synced May 17, 2026
- EUDAMED c4218816-3044-48d1-8e3f-275306e9a66e 61 fields · synced May 17, 2026
- EUDAMED 0025a5d2-f254-4a8e-831c-d2936bbdb997 61 fields · synced May 17, 2026
- EUDAMED 8f38764a-0abc-4c09-b6bc-90981bc40dc1 61 fields · synced May 17, 2026
- EUDAMED 9fd7d10f-50a6-4565-9686-bf198222abfe 61 fields · synced May 17, 2026
- EUDAMED 34356113-3e8e-47f4-a426-95bd9114cb6e 61 fields · synced May 18, 2026
- EUDAMED c610b0b8-650d-4a66-b1f4-537224fb2921 61 fields · synced May 18, 2026
- EUDAMED cc5a58de-98f4-4a25-be97-06493f5cd841 61 fields · synced May 18, 2026
- EUDAMED bb84c4f9-eb14-4263-a972-2f0b64964cf2 61 fields · synced May 18, 2026
- EUDAMED 8321eaa2-0e4b-41a8-aff9-342f9743d4eb 61 fields · synced May 18, 2026
- FDA UDI 1c6623fb-d3e3-4c6e-86f7-0707245825b4 33 fields · synced May 30, 2026