Identifiers
- 510(k) Number
- K233768 FDA 510(k)
- FDA Product Code
- LBH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3260 FDA 510(k)
- Regulation Number
- 872.3260 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Papacarie Duo is an enzyme-based cavity varnish designed for the conservative treatment of dental caries in primary and permanent teeth. Classified as a cavity varnish under FDA’s Dental category (Device Class II), it is intended for application to carious lesions to arrest progression and promote remineralization without mechanical intervention such as drilling. Its formulation leverages enzymatic action to target demineralized tooth structure, offering a non-invasive alternative to traditional restorative procedures.
Supplied as a single-use, sterile 1 mL syringe (reference code LBH), the Papacarie Duo is intended for in-office dental use and requires no anesthesia or patient discomfort. The device is regulated under FDA 510(k) clearance (K233768) as substantially equivalent to predicate cavity varnishes, with no MRI safety restrictions noted. Storage instructions specify protection from light and extreme temperatures, and it is intended for one-time application per syringe. No reusable components or additional sterilization steps are required.
Frequently asked questions
What is the Papacarie Duo used for?
The Papacarie Duo is an enzyme-based cavity varnish designed to treat early-stage dental caries in both primary and permanent teeth. It works by applying a protective layer to carious lesions, halting decay progression and encouraging natural remineralization of tooth structure. Unlike traditional restorative procedures, it avoids mechanical intervention like drilling, providing a minimally invasive alternative for conservative caries management.
How is the Papacarie Duo supplied and prepared for use?
The Papacarie Duo comes as a single-use, sterile 1 mL syringe (reference code LBH), pre-filled and ready for immediate clinical application. No additional preparation, mixing, or dilution is required. Each syringe is intended for one-time use on a single patient, ensuring sterility and preventing cross-contamination.
Is the Papacarie Duo sterile and reusable?
The Papacarie Duo is supplied in a sterile 1 mL syringe, ensuring safety for single-use applications. It is not designed for reuse or repeated sterilization. The syringe is intended for one application per patient, after which it should be discarded to maintain sterility and compliance with infection control protocols.
What storage conditions are required for the Papacarie Duo?
To preserve efficacy, the Papacarie Duo must be stored protected from light and extreme temperatures. Avoid exposure to direct sunlight, heat sources, or freezing conditions. Proper storage ensures the enzymatic activity remains intact for optimal clinical performance when applied.
Does the Papacarie Duo require any special handling or patient preparation?
No anesthesia or patient discomfort is required for application. The Papacarie Duo is formulated for in-office use and can be applied directly to carious lesions without prior drying or isolation steps. Its enzyme-based action targets demineralized tooth structure, making it suitable for sensitive patients who may avoid traditional drilling procedures.
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: Papacárie Duo by elevate Oral Care - Geriatric House Call Dentistry, Elevate Oral Care Introduces Papacárie Duo - Decisions in Dentistry, Papacárie Duo 1 mL Syringe - Oral Science
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233768 | Class II | Active |
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Manufacturer
- Manufacturer
- Elevate Oral Care, LLC
- FDA Applicant
- Elevate Oral Care
Sources (1)
- FDA 510(k) K233768 24 fields · synced Oct 1, 2026