Pulpdent Dental Bond Enchancer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K926074 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 Pulpdent Dental Bond Enhancer is a silane-based bonding agent designed to improve adhesion between organic resins, such as composites and resin cements, and porcelain surfaces. It functions as a coupling agent, enhancing bond strength by chemically linking resin materials to etched porcelain, ensuring durable restorations in dental applications.
This single-component material is supplied as a syringe-dispensed liquid, requiring application to etched and dried porcelain prior to resin bonding. It is intended for single-use in clinical settings and has received FDA 510(k) clearance under product code EBF. No additional regulatory or sterility information is specified in the provided data.
Frequently asked questions
What is the Pulpdent Dental Bond Enhancer used for in dental procedures?
The Pulpdent Dental Bond Enhancer is a silane-based bonding agent specifically designed to improve adhesion between resin materials—such as composites or resin cements—and porcelain surfaces. It acts as a coupling agent, chemically linking the resin to etched porcelain to strengthen and ensure the durability of dental restorations, such as crowns or veneers.
How is the Pulpdent Dental Bond Enhancer supplied and applied in a clinical setting?
The product is supplied as a single-component liquid in a syringe for easy dispensing. It is applied directly to etched and dried porcelain surfaces before resin bonding. The syringe design allows precise application, and it is intended for single-use per clinical procedure.
Is the Pulpdent Dental Bond Enhancer intended for reuse, or is it meant for single-use?
The Pulpdent Dental Bond Enhancer is explicitly designed for single-use in clinical settings. This ensures sterility and consistency for each application, as reuse could compromise the product’s integrity or introduce contamination risks.
What type of regulatory clearance does the Pulpdent Dental Bond Enhancer have, and how was it classified?
The Pulpdent Dental Bond Enhancer received FDA 510(k) clearance under product code EBF, which categorizes it within dental devices. The clearance was granted as substantially equivalent to a predicate device, with the decision made by the Dental (DE) Advisory Committee in 1993.
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 | Advancing Dentistry Together, Silane Bond Enhancer - PULPDENT, PULPDENT DENTAL BOND ENCHANCER (K926074) — FDA 510(k) | Innolitics, Silane Bond Enhancer (Pulpdent) | Pearson Dental, Silane Bond Enhancer, PulpDent, Prestige Dental Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K926074 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K926074 24 fields · synced Sep 18, 2026