Z5_m_c_mt Tray FULL
FDA UDIEUDAMEDClass II (US FDA UDI)
by Z-Systems AG
Identity
- Trade Name
- Z5_m_c_mt Tray FULL FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Z5_m_c_mt Tray FULL EUDAMEDSurgical Tray Z5_m_c_mt full FDA UDI
- Model / Reference
- Z5_m_c_mt Tray FULL EUDAMEDFDA UDI
- Description
- Surgical Tray Z5_m_c_mt full FDA UDI
Identifiers
- Catalog Number
- Z5_m_c_mt Tray FULL FDA UDI
- Primary DI / UDI-DI
- 07640166761778 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640166761778 EUDAMED
- 510(k) Number
- K201878 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Z5_m_c_mt Tray FULL 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 Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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Cleared under the same submission
K201878 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
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 fe4bfcd5-c27c-49af-b15d-4b2a01fe2d38 36 fields · synced Jul 11, 2026
- EUDAMED edb5b0cf-0bbd-4860-b37f-8f5088bf6614 61 fields · synced Jul 11, 2026