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Healing Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref HARR807Ref HARR505Ref HARR704Ref HARR603Ref HARR805Ref HARR609Ref HARR905Ref HARR406Ref HARR707Ref HARR403Ref HARR604Ref HARR509Ref HARR705Ref HARR405Ref HATM455Ref HARR709Ref HARR506Ref HARR804
Identity
- Trade Name
- Healing Abutment EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Healing Abutment EUDAMED08800070204771 EUDAMED
- Model / Reference
- HARR807 EUDAMEDHARR505 EUDAMEDHARR704 EUDAMEDHARR603 EUDAMEDHARR805 EUDAMEDHARR609 EUDAMEDHARR905 EUDAMEDHARR406 EUDAMEDHARR707 EUDAMEDHARR403 EUDAMEDHARR604 EUDAMEDHARR509 EUDAMEDHARR705 EUDAMEDHARR405 EUDAMEDHATM455 EUDAMEDFDA UDIHARR709 EUDAMEDHARR506 EUDAMEDHARR804 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070204832 EUDAMED08800070204634 EUDAMED08800070204740 EUDAMED08800070204672 EUDAMED08800070204818 EUDAMED08800070204726 EUDAMED08800070204863 EUDAMED08800070204580 EUDAMED08800070204771 EUDAMED08800070204559 EUDAMED08800070204689 EUDAMED08800070204665 EUDAMED08800070204757 EUDAMED08800070204573 EUDAMED08800070204245 EUDAMEDFDA UDI08800070204788 EUDAMED08800070204641 EUDAMED08800070204801 EUDAMED
- Basic UDI-DI
- B-08800070204832 EUDAMEDB-08800070204634 EUDAMEDB-08800070204740 EUDAMEDB-08800070204672 EUDAMEDB-08800070204818 EUDAMEDB-08800070204726 EUDAMEDB-08800070204863 EUDAMEDB-08800070204580 EUDAMEDB-08800070204771 EUDAMEDB-08800070204559 EUDAMEDB-08800070204689 EUDAMEDB-08800070204665 EUDAMEDB-08800070204757 EUDAMEDB-08800070204573 EUDAMEDB-08800070204245 EUDAMEDB-08800070204788 EUDAMEDB-08800070204641 EUDAMEDB-08800070204801 EUDAMED
- 510(k) Number
- K211090 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use 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
Yes
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
MR Conditional FDA UDI
Healing 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-08800070204832 | 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 (19)
- EUDAMED 5a06b4ea-fc41-46e1-88cd-59f76f05b253 61 fields · synced Sep 18, 2026
- EUDAMED 6f965765-b5c2-49b4-98d3-14639f97858a 61 fields · synced May 16, 2026
- EUDAMED 471ec889-cc87-471c-adbc-91d94c9c1562 61 fields · synced May 16, 2026
- EUDAMED 5957202e-8b44-40e6-91d1-a610bd3c4a76 61 fields · synced May 17, 2026
- EUDAMED 2559eb27-3ff6-49b6-8511-2fc3867a016a 61 fields · synced May 17, 2026
- EUDAMED f0e185ed-7fd9-4633-92fa-67936fb3aabc 61 fields · synced May 17, 2026
- EUDAMED 623ec77a-033a-43dc-8649-7488bd0fd866 61 fields · synced May 17, 2026
- EUDAMED c925218e-fd0a-4b4c-a0ae-9f69bef2b43f 61 fields · synced May 17, 2026
- EUDAMED be71bca3-e94d-49f5-9d3a-a5a7d1d102ed 61 fields · synced May 17, 2026
- EUDAMED ee07ea6d-bf86-4e60-a8f9-c633e0e9d766 61 fields · synced May 17, 2026
- EUDAMED 62b49f82-23af-43eb-a0f9-633ef5ccac0c 61 fields · synced May 17, 2026
- EUDAMED 629817e9-b9fc-41cf-a99f-d8a2a585217d 61 fields · synced May 18, 2026
- EUDAMED 5ab0c7a2-d725-47e8-9c5a-4e42747fc416 61 fields · synced May 18, 2026
- EUDAMED d2b89106-4924-48b0-b24e-2bcebcc63e67 61 fields · synced May 18, 2026
- EUDAMED 95e054cb-96d2-42b6-a962-e091857cf9de 61 fields · synced May 18, 2026
- EUDAMED 2da2cc8c-7593-4666-9993-f78d58592eaf 61 fields · synced May 18, 2026
- EUDAMED e4f347a3-45d6-464d-ab6d-48619f8392ce 61 fields · synced May 19, 2026
- EUDAMED 813edee1-5638-4ac6-9221-b3be12b86781 61 fields · synced May 19, 2026
- FDA UDI cb8b8cbb-aca2-4d5d-8746-e86af05157be 33 fields · synced May 30, 2026