Identity
- Trade Name
- Micro Esthetic A1 FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Light curing microhybrit composite FDA UDI
- Model / Reference
- 75003 FDA UDI
- Description
- Light curing microhybrit composite FDA UDI
Identifiers
- Catalog Number
- 75003 FDA UDI
- Primary DI / UDI-DI
- EBIB750031 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
Micro Esthetic A1 by bisico Bielefelder Dentalsilicone GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K984484 also covers:
- Evanesce™ Nano-Enhanced Universal Restorative A1E — Den-Mat Holdings, LLC
- Evanesce™ Nano-Enhanced Universal Restorative A1E Single Dose — 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
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
- bisico Bielefelder Dentalsilicone GmbH & Co. KG
Sources (1)
- FDA UDI 0ac0923d-c39d-43b2-a7a7-40e2fe8041c8 37 fields · synced Jun 7, 2026