Identifiers
- 510(k) Number
- K974014 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dentastic Uno is a dental adhesive classified as a cement, dental, designed for bonding dental restorations to tooth structures. It is a single-component, light-cure adhesive formulated to bond to dentin, enamel, porcelain, metal, and composite resins, providing a strong and durable bond in restorative dentistry applications.
This adhesive is supplied as a single-use, non-sterile product and requires activation via light-curing. It is intended for use in clinical settings by dental professionals. The device is regulated under FDA 510(k) clearance (K974014) and falls under Class II medical device classification (872.3275). Multiple registration numbers and FEI numbers are associated with its distribution, reflecting its availability in various dental adhesive applications.
Frequently asked questions
What types of dental materials can the Dentastic Uno adhesive bond to, and why is this important for restorative dentistry?
The Dentastic Uno adhesive is formulated to bond to dentin, enamel, porcelain, metal, and composite resins. This versatility is critical in restorative dentistry because it allows clinicians to secure a wide range of dental restorations—such as crowns, bridges, inlays, or veneers—regardless of the material composition, ensuring a durable and stable repair.
Is the Dentastic Uno adhesive single-use or reusable, and how does this affect its clinical workflow?
The Dentastic Uno adhesive is supplied as a single-use product, meaning each application requires a new unit. This design choice minimizes cross-contamination risks and ensures consistent performance, as reuse could compromise sterility or adhesive properties. Clinicians must account for this in their workflow by preparing a fresh unit for each patient.
How is the Dentastic Uno adhesive activated, and what does this mean for its application in a dental office?
The Dentastic Uno adhesive is light-cure activated, meaning it requires exposure to a dental curing light to harden and form a bond. This process allows clinicians to apply the adhesive precisely to the prepared tooth surface, then activate it immediately before placing the restoration. The light-curing step ensures proper polymerization for a strong, durable bond.
What storage conditions should be followed for the Dentastic Uno adhesive, and why are these important?
While the exact storage conditions aren’t detailed in the data, the adhesive is non-sterile and intended for clinical use by dental professionals. Proper storage—typically in a cool, dry place away from direct sunlight—is essential to maintain its shelf life and prevent degradation of its bonding properties. Since it’s single-use, expired or improperly stored units should not be used to avoid compromising patient safety or treatment outcomes.
How do I confirm the regulatory compliance of the Dentastic Uno adhesive before purchasing or using it?
The Dentastic Uno adhesive holds an FDA 510(k) clearance (K974014) and is classified under Class II (872.3275). To verify compliance, check the product’s labeling for the FDA registration number (e.g., 3012441963) or the FEI number (e.g., 3002807050) listed in the data. These identifiers confirm it meets U.S. regulatory requirements for dental adhesives. Always ensure the lot or batch number matches the manufacturer’s current compliance records.
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: DenTASTIC™ UNO™ - PULPDENT, DenTASTIC® UNO™-DUO™ - PULPDENT, DenTASTIC Uno (Pulpdent) - dentalofficedepot.com, Dentastic™ Uno (Pulpdent) | Dental Product | Pearson Dental, Pulpdent - DenTASTIC Uno
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K974014 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K974014 24 fields · synced Sep 20, 2026