Identity
- Trade Name
- Z5-BL FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Z5-BL-3612 EUDAMEDImplant + TP-SNS + BL-HC FDA UDI
- Model / Reference
- Z5-BL-3612 EUDAMEDFDA UDI
- Description
- Implant + TP-SNS + BL-HC FDA UDI
Identifiers
- Catalog Number
- Z5-BL-3612 FDA UDI
- Primary DI / UDI-DI
- 07640166768524 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640166768524 EUDAMED
- 510(k) Number
- K200386 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
Dimensions & Sizes
- Size
- Length — 12 Millimeter FDA UDIOuter Diameter — 3.6 Millimeter FDA UDI
Category: Screw endosteal dental implant, two-piece
Z5-Bl by Z-Systems AG — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Screw endosteal dental implant, two-piece.
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Cleared under the same submission
K200386 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Z-Systems AG
Sources (2)
- FDA UDI 9d7e81a8-0f45-41e8-ad71-ded9978951f5 37 fields · synced Jul 29, 2026
- EUDAMED 58183863-1729-49fd-871d-57077ca650f6 61 fields · synced Jul 29, 2026