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FreeMilling Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref FMARRH60308SRef FMARRH70208SRef FMARRH60408Ref FMARRH40409Ref FMARRH70408SRef FMARRH70208Ref FMARRH60208Ref FMARRH60508Ref FMARRH70408Ref FMARRH50308SRef FMARRH50408Ref FMARRH40509Ref FMARRH70508SRef FMARRH50208SRef FMARRH50408SRef FMARRH70308Ref FMARRH50508Ref FMATRH70158SRef FMATRN70158Ref FMASRH65208Ref FMARRH40309Ref FMARRH50308Ref FMATRH50158SRef FMATRN40309SRef FMARRH50208Ref FMASRN57208Ref FMARRH40309SRef FMATRN40159Ref FMARRH50508S
Identity
- Trade Name
- FreeMilling Abutment EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- FreeMilling Abutment EUDAMEDFMATRN40159 EUDAMED
- Model / Reference
- FMARRH60308S EUDAMEDFMARRH70208S EUDAMEDFMARRH60408 EUDAMEDFMARRH40409 EUDAMEDFMARRH70408S EUDAMEDFMARRH70208 EUDAMEDFMARRH60208 EUDAMEDFMARRH60508 EUDAMEDFMARRH70408 EUDAMEDFMARRH50308S EUDAMEDFMARRH50408 EUDAMEDFMARRH40509 EUDAMEDFMARRH70508S EUDAMEDFMARRH50208S EUDAMEDFMARRH50408S EUDAMEDFMARRH70308 EUDAMEDFMATRN40159 EUDAMEDFDA UDIFMATRN70158 EUDAMEDFDA UDIFMASRN57208 EUDAMEDFDA UDIFMATRH70158S EUDAMEDFDA UDIFMATRN40309S EUDAMEDFDA UDIFMASRH65208 EUDAMEDFDA UDIFMATRH50158S EUDAMEDFDA UDIFMARRH50508 EUDAMEDFMARRH40309 EUDAMEDFMARRH50308 EUDAMEDFMARRH50208 EUDAMEDFMARRH40309S EUDAMEDFMARRH50508S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070224298 EUDAMED08800070224328 EUDAMED08800070223741 EUDAMED08800070223666 EUDAMED08800070224342 EUDAMED08800070223765 EUDAMED08800070223727 EUDAMED08800070223758 EUDAMED08800070223789 EUDAMED08800070224250 EUDAMED08800070223703 EUDAMED08800070223673 EUDAMED08800070224359 EUDAMED08800070224243 EUDAMED08800070224267 EUDAMED08800070223772 EUDAMED08800070223567 EUDAMEDFDA UDI08800070223628 EUDAMEDFDA UDI08800070223406 EUDAMEDFDA UDI08800070224083 EUDAMEDFDA UDI08800070224137 EUDAMEDFDA UDI08800070223321 EUDAMEDFDA UDI08800070224045 EUDAMEDFDA UDI08800070223710 EUDAMED08800070223659 EUDAMED08800070223697 EUDAMED08800070223680 EUDAMED08800070224212 EUDAMED08800070224274 EUDAMED
- Basic UDI-DI
- B-08800070224298 EUDAMEDB-08800070224328 EUDAMEDB-08800070223741 EUDAMEDB-08800070223666 EUDAMEDB-08800070224342 EUDAMEDB-08800070223765 EUDAMEDB-08800070223727 EUDAMEDB-08800070223758 EUDAMEDB-08800070223789 EUDAMEDB-08800070224250 EUDAMEDB-08800070223703 EUDAMEDB-08800070223673 EUDAMEDB-08800070224359 EUDAMEDB-08800070224243 EUDAMEDB-08800070224267 EUDAMEDB-08800070223772 EUDAMEDB-08800070223710 EUDAMEDB-08800070224083 EUDAMEDB-08800070223628 EUDAMEDB-08800070223321 EUDAMEDB-08800070223659 EUDAMEDB-08800070223697 EUDAMEDB-08800070224045 EUDAMEDB-08800070224137 EUDAMEDB-08800070223680 EUDAMEDB-08800070223406 EUDAMEDB-08800070224212 EUDAMEDB-08800070223567 EUDAMEDB-08800070224274 EUDAMED
- 510(k) Number
- K231557 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
FreeMilling 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-08800070224298 | 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 (36)
- EUDAMED 731d9336-58e5-4d88-a61d-668a121629c9 61 fields · synced Sep 18, 2026
- EUDAMED 03b88a1a-be07-4438-94f9-cd8944e2d6a9 61 fields · synced May 17, 2026
- EUDAMED 1b349db4-e9d7-4f46-904b-5bde80ba0b05 61 fields · synced May 17, 2026
- EUDAMED f9970cc9-aff8-471f-8981-8a00230034db 61 fields · synced May 17, 2026
- EUDAMED 76388a7b-6bdb-4957-a727-dc6df59bbed5 61 fields · synced May 18, 2026
- EUDAMED f7862f78-61a3-4aff-bd10-d1b32eb96b1a 61 fields · synced May 18, 2026
- EUDAMED f6cb0555-3d1a-46bc-bb9b-d4abb5909baa 61 fields · synced May 18, 2026
- EUDAMED 63076d60-7a95-4fab-a9cb-cea9e429d38e 61 fields · synced May 18, 2026
- EUDAMED d4e0d83a-426d-4c88-83c8-9685304b8114 61 fields · synced May 18, 2026
- EUDAMED 8ec41b49-5c72-4ce0-acb1-be02530cfb13 61 fields · synced May 18, 2026
- EUDAMED 1ddd7514-655a-482f-b895-cbfc8ec1ff82 61 fields · synced May 18, 2026
- EUDAMED e1533b56-7322-448b-9e2a-4bfe52be6e38 61 fields · synced May 18, 2026
- EUDAMED 79a21763-a202-4b70-811c-80fcfe6f4c92 61 fields · synced May 18, 2026
- EUDAMED 133f9581-410c-4fba-b55e-7e3b02047836 61 fields · synced May 18, 2026
- EUDAMED 91f4ee62-7d2b-4ede-85f7-fad79a647b96 61 fields · synced May 18, 2026
- EUDAMED f42830cc-829c-4481-9bb7-13f9bd2928af 61 fields · synced May 18, 2026
- FDA UDI 386516d6-cf9e-4e70-aeb7-50d4e052939f 33 fields · synced May 30, 2026
- FDA UDI 593b7c4e-76ac-465f-9807-7b88ba105659 33 fields · synced May 30, 2026
- FDA UDI 119d85c0-1169-495a-8d5d-b81835c85d23 33 fields · synced May 30, 2026
- FDA UDI b1bb3900-6e6f-466f-9951-eb8d65873d66 33 fields · synced May 30, 2026
- FDA UDI 42f9a22a-282b-4492-ad8e-3869034c198a 33 fields · synced May 30, 2026
- FDA UDI 89e624fc-c092-4701-a9d7-f66dec7db0cc 33 fields · synced May 30, 2026
- FDA UDI 1a4bcad6-f730-41a8-8d95-bf966a8ba1c6 33 fields · synced May 30, 2026
- EUDAMED 635d8a19-0024-4dde-a2c4-db85ca6e1404 61 fields · synced Jul 8, 2026
- EUDAMED a6c47f7b-2f1d-4f91-ba6f-46f629fb19f0 61 fields · synced Jul 9, 2026
- EUDAMED 4f08efad-c40a-4ee4-b8ea-d369821bdb3f 61 fields · synced Jul 9, 2026
- EUDAMED cad5519b-fb9c-45f3-8115-e03f341b5cb0 61 fields · synced Jul 9, 2026
- EUDAMED 7cb54104-33fc-4c69-b3e3-2b0ba7d2a9fa 61 fields · synced Jul 12, 2026
- EUDAMED c2a24c02-1544-4e97-aa93-17c094340bfc 61 fields · synced Jul 12, 2026
- EUDAMED 9fffe884-b9c5-4c76-b2d3-f5ba1ad182d8 61 fields · synced Jul 13, 2026
- EUDAMED d932fa1c-2a43-4329-b6c1-236cd83bc287 61 fields · synced Jul 14, 2026
- EUDAMED 3386e3aa-ea64-437f-853c-b5c1282e5350 61 fields · synced Jul 15, 2026
- EUDAMED bb53eb25-12a1-4974-b752-5c64ef9dbd22 61 fields · synced Jul 17, 2026
- EUDAMED 0233668f-3bd3-4697-9c43-1585f6a24c76 61 fields · synced Jul 19, 2026
- EUDAMED a117916b-8f5f-4cb1-89df-ca22ec927bee 61 fields · synced Jul 24, 2026
- EUDAMED 0a2759cd-162a-4a34-8416-7acf36978cef 61 fields · synced Jul 30, 2026