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IH2 SLA Fixture
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref AIH2FR5008SModel IH IMPLANT SYSTEM
Identity
- Trade Name
- IH2 SLA Fixture EUDAMEDIH2 Fixture SLA FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- IH2 SLA Fixture EUDAMEDSEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x8.5mm FDA UDI
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDAIH2FR5008S EUDAMEDFDA UDI
- Description
- SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x8.5mm FDA UDI
Identifiers
- Catalog Number
- AIH2FR5008S FDA UDI
- Primary DI / UDI-DI
- 08800041300983 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800041300983 EUDAMED
- 510(k) Number
- K153521 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
IH2 SLA Fixture 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-08800041300983 | 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 (2)
- EUDAMED 16bc36e9-0218-4a6c-a883-95425d206c37 61 fields · synced Jun 20, 2026
- FDA UDI 71253ad9-5608-4235-828e-13717a4d71a6 36 fields · synced May 30, 2026