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Ti Link Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref TLARRN4010Ref TLATMH4020SRef TLARRH4010SRef TLARRN4020S
Identity
- Trade Name
- Ti Link Abutment EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Ti Link Abutment EUDAMED
- Model / Reference
- TLARRN4010 EUDAMEDTLATMH4020S EUDAMEDFDA UDITLARRH4010S EUDAMEDTLARRN4020S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070220290 EUDAMED08800070220375 EUDAMEDFDA UDI08800070220443 EUDAMED08800070220474 EUDAMED
- Basic UDI-DI
- B-08800070220290 EUDAMEDB-08800070220375 EUDAMEDB-08800070220443 EUDAMEDB-08800070220474 EUDAMED
- 510(k) Number
- K232170 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
Ti Link 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-08800070220290 | 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 (5)
- EUDAMED 82c8fb88-3b0b-4356-9b2a-3e15f4fec5bc 61 fields · synced Sep 18, 2026
- EUDAMED 2b8e8b02-e67f-46bc-bb6d-2b913316cc7f 61 fields · synced May 18, 2026
- EUDAMED bfc96947-2c5b-4f7e-b8b1-90e1a24cee3e 61 fields · synced May 18, 2026
- EUDAMED e99dcd31-4bb5-4df8-8106-dccceafa1fb8 61 fields · synced May 18, 2026
- FDA UDI 81a5fcba-a402-4968-9837-d932db912e68 33 fields · synced May 30, 2026