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Seal-Rite Low Viscosity Pit and Fissure Sealant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K932794

by Pulpdent Corporation

Identifiers

510(k) Number
K932794 FDA 510(k)
FDA Product Code
EBC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3765 FDA 510(k)
Regulation Number
872.3765 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Seal-Rite Low Viscosity Pit and Fissure Sealant is a dental adhesive classified as a Pit and Fissure Sealant, and Conditioner (per FDA nomenclature). It is designed to prevent dental caries by sealing the deep grooves and fissures on the chewing surfaces of teeth, reducing bacterial penetration and plaque accumulation. Its low-viscosity formulation ensures enhanced flow and adaptation to tooth morphology, improving coverage in complex anatomical areas. The material incorporates fluoride-releasing properties to further support remineralization and caries resistance.

This sealant is supplied as a light-cured, single-use, non-radiopaque product in a 1.2 mL syringe kit, intended for use in dental offices. It is not classified as MRI-safe or reusable; proper disposal follows standard dental waste protocols. The device is authorized under FDA 510(k) clearance (K932794) and falls under Class II regulatory classification (regulation number 872.3765). Storage requires protection from moisture and extreme temperatures, adhering to manufacturer guidelines for shelf life and handling.

Frequently asked questions

What is the primary purpose of the Seal-Rite Low Viscosity Pit and Fissure Sealant, and how does its low-viscosity formula benefit dental practitioners?

The Seal-Rite Low Viscosity Pit and Fissure Sealant is designed to prevent dental caries by sealing deep grooves and fissures on tooth surfaces, reducing bacterial penetration and plaque buildup. Its low-viscosity formula enhances flow and adaptation to the tooth’s anatomy, ensuring better coverage in complex or irregular fissures compared to higher-viscosity sealants. This improves the sealant’s effectiveness in protecting vulnerable areas from decay.

How is the Seal-Rite Low Viscosity sealant supplied, and is it intended for single-use or reusable applications?

The sealant is supplied as a single-use, light-cured product in a 1.2 mL syringe kit, specifically packaged for dental office use. It is not reusable—each syringe is intended for one application to maintain sterility and performance. After use, disposal follows standard dental waste protocols.

What storage conditions are required for the Seal-Rite Low Viscosity sealant to ensure its shelf life and integrity?

The sealant must be stored protected from moisture and extreme temperatures to preserve its properties. Adherence to the manufacturer’s guidelines for shelf life and handling is critical, as exposure to humidity or temperature fluctuations could compromise its viscosity, curing performance, or fluoride-releasing capabilities.

Is this sealant radiopaque, and what safety considerations should clinicians keep in mind during use?

The Seal-Rite Low Viscosity sealant is non-radiopaque, meaning it will not appear on dental X-rays. Clinicians should account for this when planning diagnostic imaging post-application, as the sealant’s presence may not be visible on radiographs. Additionally, it is not MRI-safe, so patients should avoid MRI scans after application unless clinically necessary.

What regulatory pathway does the Seal-Rite Low Viscosity sealant follow, and what does this mean for its use in clinical practice?

The sealant is authorized under FDA 510(k) clearance (K932794) and classified as Class II, indicating it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance means it meets FDA standards for safety and effectiveness as a Pit and Fissure Sealant and Conditioner, allowing its use in clinical practice as described in the labeling. The regulatory classification does not imply its clinical indication but confirms its compliance with FDA requirements.

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: Seal-Rite™ Pit & Fissure Sealant - PULPDENT, PDF PULPDENT Seal Rite, Seal-Rite SEAL-LV Low Viscosity Pit & Fissure Sealant

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) K932794 24 fields · synced Sep 20, 2026