Identity
- Trade Name
- Cement Spatula EUDAMEDFDA UDI
- Generic Name
- Dental spatula, reusable FDA UDI
- Device Name
- Non-Sterile Dental Mixing Accessories EUDAMEDCement Spatula FDA UDI
- Model / Reference
- 50Z502 EUDAMEDFDA UDI
- Description
- Cement Spatula FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161304131 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840161300063B EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L159013,V9099 EUDAMED
- GMDN Term
- Dental spatula, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 162 Millimeter FDA UDIWidth — 6 Millimeter FDA UDIHeight — 10 Millimeter FDA UDI
Cement Spatula by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0840161300063B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (2)
- EUDAMED 2da64a20-8bcb-4308-a37e-24c757704bdd 61 fields · synced Sep 17, 2026
- FDA UDI e3541b24-b8d3-49cf-af34-39415da5831a 34 fields · synced May 30, 2026