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Temporary Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref TARRN4010SRef TASRN4530SRef TARRN4030SRef TARRN4010Ref TARRN4030Ref TARRH4030Ref TARRH4010SRef TARRH4030S
Identity
- Trade Name
- Temporary Abutment EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Temporary Abutment EUDAMED
- Model / Reference
- TARRN4010S EUDAMEDTASRN4530S EUDAMEDFDA UDITARRN4030S EUDAMEDTARRN4010 EUDAMEDTARRN4030 EUDAMEDTARRH4030 EUDAMEDTARRH4010S EUDAMEDTARRH4030S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070219393 EUDAMED08800070219287 EUDAMEDFDA UDI08800070219409 EUDAMED08800070219188 EUDAMED08800070219195 EUDAMED08800070219171 EUDAMED08800070219379 EUDAMED08800070219386 EUDAMED
- Basic UDI-DI
- B-08800070219393 EUDAMEDB-08800070219287 EUDAMEDB-08800070219409 EUDAMEDB-08800070219188 EUDAMEDB-08800070219195 EUDAMEDB-08800070219171 EUDAMEDB-08800070219379 EUDAMEDB-08800070219386 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
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
Temporary 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-08800070219393 | 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 (9)
- EUDAMED aca2f35a-8671-4bfb-90ec-0b3f9a5c2324 61 fields · synced Sep 18, 2026
- EUDAMED 62ee45fa-4801-4d85-8749-32c3ee16e699 61 fields · synced May 17, 2026
- EUDAMED 9eb0836f-2791-495f-8ea2-c6e6b6d4529a 61 fields · synced May 17, 2026
- EUDAMED 1039ccc2-64ee-4ada-a727-a7f525d7fe10 61 fields · synced May 18, 2026
- EUDAMED 5f81d1f0-4d80-4b63-b0ab-8f0ceb386723 61 fields · synced May 18, 2026
- EUDAMED 682d05f2-cb6a-42f0-8b37-323b7ccc1e45 61 fields · synced May 18, 2026
- EUDAMED c5111557-d02e-4430-a8ef-7d8de1e5b528 61 fields · synced May 18, 2026
- EUDAMED 75d4c723-73a8-4a96-8619-cae331af4030 61 fields · synced May 18, 2026
- FDA UDI e6fd568a-44a1-4c25-8c76-b724c7f3f42b 33 fields · synced May 29, 2026