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Multi-unit Temporary Cylinder
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref AMTC100HModel IH IMPLANT SYSTEM
Identity
- Trade Name
- Multi-unit Temporary Cylinder EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Multi-unit Temporary Cylinder EUDAMEDSEWON MEDIX IH Multi-unit Temporary Cylinder Bridge Set Product, Ø4.8x12.0mm FDA UDI
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDAMTC100H EUDAMEDFDA UDI
- Description
- SEWON MEDIX IH Multi-unit Temporary Cylinder Bridge Set Product, Ø4.8x12.0mm FDA UDI
Identifiers
- Catalog Number
- AMTC100H FDA UDI
- Primary DI / UDI-DI
- 08800041355983 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800041355983 EUDAMED
- FDA Product Code
- NDP 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 I FDA UDI
- Regulation Number
- 872.3980 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
Multi-unit Temporary Cylinder 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-08800041355983 | 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 d1599732-b9cd-4271-8cfc-4f1cef53b080 61 fields · synced Jun 8, 2026
- FDA UDI ccd510dc-ddc1-4b10-92c3-6cc4b8f4de4f 36 fields · synced May 30, 2026