Identity
- Trade Name
- Mixing Well 144pk EUDAMEDMixing Well EUDAMEDFDA UDI
- Generic Name
- General-purpose bowl, reusable FDA UDI
- Device Name
- Non-Sterile Dental Mixing Accessories EUDAMEDMixing Well 144 pk FDA UDI
- Model / Reference
- 20Z496V EUDAMEDFDA UDI20Z496 EUDAMED
- Description
- Mixing Well 144 pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840161304152 EUDAMEDFDA UDI00840161304155 EUDAMED
- Basic UDI-DI
- 0840161300063B EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- General-purpose bowl, 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
Yes
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 — 254 Millimeter FDA UDIWidth — 305 Millimeter FDA UDIHeight — 16 Millimeter FDA UDI
Mixing Well 144pk 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 (3)
- EUDAMED b9c0254e-02e1-405a-a74a-12b25d517a2b 61 fields · synced Aug 4, 2026
- EUDAMED 98c2775b-8380-4133-aec7-171527b17723 61 fields · synced May 17, 2026
- FDA UDI 12930f72-334e-4bcc-94a9-6d8d30d15311 34 fields · synced May 30, 2026