← Back to catalogue
ZENEX PLUS Fixture Set
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ZPSR4007SRef ZPRW5008S
Identity
- Trade Name
- ZENEX PLUS Fixture Set EUDAMEDFDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- ZENEX PLUS Fixture Set (Fixture + Cover Screw) EUDAMED
- Model / Reference
- ZPSR4007S EUDAMEDFDA UDIZPRW5008S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070229422 EUDAMEDFDA UDI08800070230176 EUDAMED
- Basic UDI-DI
- B-08800070229422 EUDAMEDB-08800070230176 EUDAMED
- 510(k) Number
- K211090 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 PLUS Fixture Set 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-08800070229422 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Izenimplant Co., Ltd
- EUDAMED SRN
- KR-MF-000026205
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED ef7977a9-273a-4059-86ec-3e3bed01a7df 61 fields · synced Sep 18, 2026
- EUDAMED 5787bd03-dd1e-465d-9d7d-c00eed124778 61 fields · synced May 16, 2026
- FDA UDI 321b549e-60f7-4c6d-9927-e72df2d84ce6 33 fields · synced May 30, 2026