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Evanesce™ Nano-Enhanced Universal Restorative A1E Single Dose
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Evanesce™ Nano-Enhanced Universal Restorative A1E Single Dose FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Dental Composite Resin FDA UDI
- Model / Reference
- 322514 FDA UDI
- Description
- Dental Composite Resin FDA UDI
Identifiers
- Catalog Number
- 322514 FDA UDI
- Primary DI / UDI-DI
- 00359883004804 FDA UDI
- 510(k) Number
- K984484 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 — 0.25 Gram FDA UDI
Category: Dental composite resin
Evanesce™ Nano-Enhanced Universal Restorative A1E Single Dose by Den-Mat Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K984484 also covers:
- Evanesce™ Nano-Enhanced Universal Restorative A1E — Den-Mat Holdings, LLC
- Evanesce™ Nano-Enhanced Universal Restorative A1U Single Dose — Den-Mat Holdings, LLC
- Evanesce™ Nano-Enhanced Universal Restorative A2D Single Dose — Den-Mat Holdings, LLC
- Evanesce™ Nano-Enhanced Universal Restorative A2E — Den-Mat Holdings, LLC
- Evanesce™ Nano-Enhanced Universal Restorative A2E Single Dose — Den-Mat Holdings, LLC
- Evanesce™ Nano-Enhanced Universal Restorative A2U — Den-Mat Holdings, LLC
- Evanesce™ Nano-Enhanced Universal Restorative A2U Single Dose — Den-Mat Holdings, LLC
- Evanesce™ Nano-Enhanced Universal Restorative A3.5D Single Dose — Den-Mat Holdings, LLC
- Evanesce™ Nano-Enhanced Universal Restorative A3.5E Single Dose — Den-Mat Holdings, LLC
- Evanesce™ Nano-Enhanced Universal Restorative A3.5U — Den-Mat Holdings, LLC
- Evanesce™ Nano-Enhanced Universal Restorative A3D Single Dose — Den-Mat Holdings, LLC
- Evanesce™ Nano-Enhanced Universal Restorative A3E Single Dose — Den-Mat Holdings, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI 910f19af-4c3b-4c71-ad47-ce3d3e501e64 38 fields · synced Jun 9, 2026