Identity
- Trade Name
- Znano EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Znano EUDAMEDZNano Shade-Adaptive Universal Nanocomposite, Low Flow, A3/A3.5/B3, 4 g FDA UDI
- Model / Reference
- 90-00144 EUDAMEDFDA UDI
- Description
- ZNano Shade-Adaptive Universal Nanocomposite, Low Flow, A3/A3.5/B3, 4 g FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816594025882 EUDAMEDFDA UDI
- Basic UDI-DI
- 081659402D01TF030WX EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 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
Yes
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
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 25 Gram FDA UDI
Znano by Zest Anchors, LLC — Class IIa — 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 | 081659402D01TF030WX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Zest Anchors, LLC
- EUDAMED SRN
- US-MF-000009815
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 9be7f2ef-18ed-4701-9399-0553a80e3cf1 61 fields · synced Jul 19, 2026
- FDA UDI 58e50108-0160-4d9e-95f4-67f746e003f9 36 fields · synced May 30, 2026