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ZENEX MULTI Fixture Set (Fixture + Cover Screw)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ZMTW6006S
Identity
- Trade Name
- ZENEX MULTI Fixture Set FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- ZENEX MULTI Fixture Set (Fixture + Cover Screw) EUDAMED
- Model / Reference
- ZMTW6006S EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800070230343 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800070230343 EUDAMED
- 510(k) Number
- K233163 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Germany 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
MR Conditional FDA UDI
ZENEX MULTI Fixture Set (Fixture + Cover Screw) 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-08800070230343 | 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 (2)
- EUDAMED 8c42d911-7e19-4fd3-b1ee-12b36dc57ba4 61 fields · synced Sep 18, 2026
- FDA UDI 4b831f40-713e-4998-ba9f-ab809c079c44 33 fields · synced May 30, 2026