Identifiers
- 510(k) Number
- K210045 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Activa Presto Pack is a light-cure composite restorative material designed for dental restorations. It is a universal, stackable composite that mimics the properties of natural teeth, offering strength, durability, and resistance to wear and fracture. The material is bioactive, releasing and recharging calcium, phosphate, and fluoride to support remineralisation.
This device is supplied as a single-use pack and is intended for use in dental clinics. It is not sterile and requires preparation prior to application. The product is authorised under FDA 510(k) clearance (K210045) and falls under the Dental (DE) advisory committee. No MRI safety or reusable specifications are noted in the regulatory data.
Frequently asked questions
What is the Activa Presto Pack used for in dental procedures?
The Activa Presto Pack is a light-cure composite restorative material designed for dental restorations. It is a universal, stackable composite that mimics the properties of natural teeth, providing strength, durability, and resistance to wear and fracture. Its bioactive properties also help release and recharge calcium, phosphate, and fluoride to support remineralisation of treated teeth.
Is the Activa Presto Pack intended for single-use or can it be reused?
The Activa Presto Pack is explicitly supplied as a single-use pack. This means each pack is intended for one application only, ensuring sterility and safety standards are maintained for each patient.
How should the Activa Presto Pack be prepared before use?
The Activa Presto Pack is not sterile as supplied, so it requires preparation prior to application. This typically involves opening the pack and mixing or handling the composite material according to the manufacturer’s instructions, ensuring it is ready for light-curing in dental restorations.
What regulatory pathway was followed for FDA clearance of the Activa Presto Pack?
The Activa Presto Pack received FDA clearance through a 510(k) submission, specifically under the traditional clearance type. It was reviewed by the Dental (DE) advisory committee and determined to be substantially equivalent to a legally marketed predicate device. The clearance number is K210045.
Are there different sizes or models available for the Activa Presto Pack?
The provided regulatory data does not specify distinct sizes or models for the Activa Presto Pack. However, as a universal composite, it is likely designed to accommodate various restoration needs within standard dental procedures. For exact sizing or model variations, refer to the manufacturer’s product documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ACTIVA™ Presto™ - PULPDENT, ACTIVA BioACTIVE and ACTIVA Presto - PULPDENT, Activa™ Presto™ - Pulpdent, ACTIVA PRESTO PACK (K210045) - FDA 510 (k), ACTIVA™ Presto™ - PULPDENT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210045 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K210045 24 fields · synced Sep 18, 2026