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Pulpdent Dental Bond Enhancer 2-B

FDA 510(k)

Class II (US FDA 510(k))

510(k) K931710

by Pulpdent Corporation

Identifiers

510(k) Number
K931710 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 Dental Bond Enhancer 2-B is a Tooth Bonding Agent, Resin, designed to improve adhesion between resin-based materials and porcelain surfaces. This single-component solution enhances the bond strength of composites and resin cements to etched and dried porcelain, ensuring durable dental restorations.

Supplied as a single-use syringe, the Dental Bond Enhancer 2-B is intended for use in dental settings and has received FDA 510(k) clearance under classification KLE. It is not sterile and must be handled in accordance with standard dental practice guidelines. The device is regulated under 21 CFR 872.3200 and is classified as a Class II medical device.

Frequently asked questions

What is the primary purpose of the Pulpdent Dental Bond Enhancer 2-B in dental procedures?

The Pulpdent Dental Bond Enhancer 2-B is designed to improve adhesion between resin-based materials (such as composites and resin cements) and porcelain surfaces. By applying it to etched and dried porcelain, it enhances bond strength, ensuring more durable dental restorations.

How is the Dental Bond Enhancer 2-B supplied, and is it intended for single-use?

The Dental Bond Enhancer 2-B is supplied as a single-use syringe, which means each syringe is intended for one application only. This design helps maintain sterility and hygiene in dental settings.

Is the Pulpdent Dental Bond Enhancer 2-B sterile, and how should it be handled?

The Dental Bond Enhancer 2-B is not sterile, so it must be handled in accordance with standard dental practice guidelines to prevent contamination. This includes following proper aseptic techniques during use.

What regulatory pathway was followed for FDA clearance of this device?

The Pulpdent Dental Bond Enhancer 2-B received FDA clearance through a 510(k) submission, classified under KLE (Tooth Bonding Agent, Resin). The device was determined to be substantially equivalent to a predicate product and was reviewed by the Dental Expert Panel (DE). The clearance was granted on August 24, 1993, under 21 CFR 872.3200 as a Class II medical device.

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 DENTAL BOND ENHANCER 2-B - Innolitics, Pulpdent | Advancing Dentistry Together, Pulpdent Dental Bond Enhancer 2-b - Beudamed, Silane Bond Enhancer - PULPDENT, Pulpdent Dental Bond Enhancer 2-b 510 (k) FDA Premarket Notification ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation
FDA Applicant
Pulpdent Corp.

Sources (1)

  • FDA 510(k) K931710 24 fields · synced Sep 18, 2026