Identifiers
- 510(k) Number
- K993683 FDA 510(k)
- FDA Product Code
- KLE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3200 FDA 510(k)
- Regulation Number
- 872.3200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulpdent Uno-Duo is a Tooth Bonding Agent, Resin, designed for dental applications. It functions as a dual-cure adhesive system, enabling both self-cure and dual-cure bonding capabilities for dental restorations. This adhesive promotes strong adhesion between dental materials and tooth structure, facilitating durable restorative procedures.
Supplied as a kit, the Uno-Duo system includes resin components (UNO and DUO), an etchant (Etch-Rite), and applicators. It is intended for single-use in clinical settings and requires proper handling to maintain sterility. The device is classified under FDA 510(k) clearance (K993683) and adheres to dental regulatory standards, ensuring compliance with 21 CFR 872.3200. No MRI safety or reusable specifications are indicated.
Frequently asked questions
What types of dental restorations is the Pulpdent Uno-Duo designed to bond with, and how does its dual-cure feature benefit the clinician?
The Pulpdent Uno-Duo is a dual-cure adhesive system designed to bond dental restorations to tooth structure, ensuring strong adhesion for durable procedures. The dual-cure feature allows the clinician to initiate bonding with either self-cure or dual-cure methods, providing flexibility depending on the clinical setting or patient-specific needs. This versatility helps achieve reliable results in various restorative applications, such as fillings or crowns.
Is the Pulpdent Uno-Duo intended for reuse, or is it meant to be used only once per patient? How should sterility be maintained?
The Pulpdent Uno-Duo is explicitly designed for single-use in clinical settings. Since it comes as a kit with resin components, etchant, and applicators, proper handling is required to preserve sterility. Once opened or used, the components should not be reused to prevent contamination or compromise of adhesion quality.
What components are included in the Uno-Duo kit, and how are they typically applied during a dental procedure?
The Uno-Duo kit includes resin components labeled UNO and DUO, an etchant called Etch-Rite, and applicators. During use, the etchant prepares the tooth surface, followed by application of the resin components to promote bonding between the restoration and tooth structure. The dual-cure system allows the clinician to activate bonding either chemically (self-cure) or with light (dual-cure), depending on the procedure.
Does the Pulpdent Uno-Duo have any special storage requirements, and how should it be stored to ensure optimal performance?
While specific storage instructions aren’t detailed in the data, as a single-use dental adhesive system, the Uno-Duo should be stored in a cool, dry place, protected from direct sunlight and extreme temperatures. Proper sealing of the kit components after opening helps maintain sterility and prevents degradation of the resin or etchant, ensuring reliable performance when used.
What regulatory pathway was followed for FDA clearance of the Pulpdent Uno-Duo, and how does this classification affect its use in dental practices?
The Pulpdent Uno-Duo received FDA 510(k) clearance (K993683) under the Traditional 510(k) pathway, with a decision classification of *Substantially Equivalent* to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously cleared dental bonding agent, ensuring compliance with 21 CFR 872.3200. Clinicians can rely on this clearance as evidence of safety and effectiveness for bonding dental restorations in routine 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: Pulpdent DenTASTIC UNO-DUO Adhesive Kit - amerdental.com, Dentastic Uno-Duo Adhesive - Prime Dental Supply, Dentastic Uno™-Duo™ Adhesive DUO Dental Adhesive Pulpdent DUO ..., Pulpdent - DenTASTIC Uno Duo - dentalcity.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993683 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K993683 24 fields · synced Sep 18, 2026