Identity
- Trade Name
- Vittra APS Unique FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Light-curing composite for all dental shades for use in anterior and posterior restorations, recommended for all classes of cavities. The optical properties of Vittra APS Unique come from a fine balance between refractive indices of the dental structure versus that of the resin, which results in the propagation of the base color (dental remnant) through the resin structure. This effect causes the resin to "assume" (or transmit) the tooth color. It has a fundamental role, the loads, the well-balanced opacity of the product and the aesthetic of the APS system. FDA UDI
- Model / Reference
- 4g FDA UDI
- Description
- Light-curing composite for all dental shades for use in anterior and posterior restorations, recommended for all classes of cavities. The optical properties of Vittra APS Unique come from a fine balance between refractive indices of the dental structure versus that of the resin, which results in the propagation of the base color (dental remnant) through the resin structure. This effect causes the resin to "assume" (or transmit) the tooth color. It has a fundamental role, the loads, the well-balanced opacity of the product and the aesthetic of the APS system. FDA UDI
Identifiers
- Catalog Number
- 4000055659 FDA UDI
- Primary DI / UDI-DI
- 07899633829330 FDA UDI
- 510(k) Number
- K210231 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
Yes
FDA UDI
Category: Dental composite resin
Vittra APS Unique by Dentscare Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Capo Universal, 6 g — Schütz Dental GmbH · Class II
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Cleared under the same submission
K210231 also covers:
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
- Dentscare Ltda
Sources (1)
- FDA UDI 4a34b842-132e-498b-b94d-80ebe3f36695 35 fields · synced Jun 1, 2026