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IH Healing Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IHHAR657Model IH IMPLANT SYSTEM Ref IHHAR453Ref IHHAR407Ref IHHAR903Ref IHHAR907Ref IHHAR405Ref IHHAR403Ref IHHAR905
Identity
- Trade Name
- IH Healing Abutment EUDAMEDIH2 Healing Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- IH Healing Abutment EUDAMEDSEWON MEDIX IH Healing Abutment Regular, Ø4.5x3.0mm FDA UDI
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDIHHAR657 EUDAMEDIHHAR453 EUDAMEDFDA UDIIHHAR407 EUDAMEDIHHAR903 EUDAMEDIHHAR907 EUDAMEDIHHAR405 EUDAMEDIHHAR403 EUDAMEDIHHAR905 EUDAMED
- Description
- SEWON MEDIX IH Healing Abutment Regular, Ø4.5x3.0mm FDA UDI
Identifiers
- Catalog Number
- IHHAR453 FDA UDI
- Primary DI / UDI-DI
- 08800041302444 EUDAMED08800041302307 EUDAMEDFDA UDI08800041302291 EUDAMED08800041359264 EUDAMED08800041359288 EUDAMED08800041302284 EUDAMED08800041302277 EUDAMED08800041359271 EUDAMED
- Basic UDI-DI
- B-08800041302444 EUDAMEDB-08800041302307 EUDAMEDB-08800041302291 EUDAMEDB-08800041359264 EUDAMEDB-08800041359288 EUDAMEDB-08800041302284 EUDAMEDB-08800041302277 EUDAMEDB-08800041359271 EUDAMED
- 510(k) Number
- K153521 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
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
IH Healing Abutment by SEWONMEDIX Inc. — 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-08800041302444 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (9)
- EUDAMED 1ac71ac7-2416-4d42-b1d6-0565c365aa32 61 fields · synced Oct 1, 2026
- EUDAMED 8cd66ae9-8e8a-4bda-99a8-db392c737b20 61 fields · synced May 16, 2026
- EUDAMED e404ddf3-f139-4d14-8bba-8bf72711a74d 61 fields · synced May 17, 2026
- EUDAMED f400a908-a83d-4a37-860f-2ed30f8399ac 61 fields · synced May 17, 2026
- EUDAMED 7cdf7df4-2132-425c-a655-ba9ce7d243ba 61 fields · synced May 18, 2026
- EUDAMED 4c9757cd-d26a-4c09-bd9f-7a9f0db0a7ef 61 fields · synced May 18, 2026
- EUDAMED 3e3c56d9-d946-485a-abcb-5a1d16acb639 61 fields · synced May 18, 2026
- EUDAMED a7136e50-93d5-442c-a4eb-6cd9c5e790a1 61 fields · synced May 19, 2026
- FDA UDI 50688f0a-2974-4ad2-84f7-5455adeee280 36 fields · synced May 30, 2026