Bisco Pit and Fissure Sealant
FDA 510(k)Class II (US FDA 510(k))
by Bisco Inc.
Identifiers
- 510(k) Number
- K874556 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 Bisco Pit and Fissure Sealant is a dental device classified as a Sealant, Pit and Fissure, and Conditioner (Product Code: EBC). It is designed to prevent dental caries by sealing the deep grooves and fissures on the chewing surfaces of molars and premolars, reducing the risk of tooth decay by limiting bacterial access to these vulnerable areas.
This device is supplied as a single-use dental material and is intended for use in clinical dental settings. It is regulated under FDA 510(k) clearance (K874556) as a Class II device under Special Controls, with an authorization date of January 28, 1988. The product adheres to regulatory standards for dental sealants and is distributed in sizes and formulations consistent with its intended application in pediatric and adult dentistry.
Frequently asked questions
What is the primary purpose of the Bisco Pit and Fissure Sealant in dental care?
The Bisco Pit and Fissure Sealant is designed to prevent dental caries by sealing the deep grooves and fissures on the chewing surfaces of molars and premolars. This reduces the risk of tooth decay by limiting bacterial access to these vulnerable areas, effectively acting as a protective barrier.
Is the Bisco Pit and Fissure Sealant intended for single-use or reusable applications?
The Bisco Pit and Fissure Sealant is explicitly supplied as a single-use dental material, meaning each application requires a new unit. This ensures sterility and hygiene in clinical settings, as reuse is not recommended or supported by its design.
How is this sealant regulated in the U.S., and what does that mean for clinicians?
The Bisco Pit and Fissure Sealant is classified as a Class II medical device under FDA regulations and holds a 510(k) clearance (K874556). This means it has undergone FDA review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for dental sealants. Clinicians can rely on its compliance with FDA-mandated controls for dental sealants.
Where and how is the Bisco Pit and Fissure Sealant distributed, and what sizes/formulations are available?
The product is distributed by Bisco, Inc. (based in Downers Grove, IL) and is formulated specifically for clinical dental use in both pediatric and adult patients. While exact sizes or formulations aren’t detailed in the data, the device is supplied in multiple FEI numbers (e.g., 3038718579, 2523320), indicating variations likely tailored to different patient needs or application techniques. Contacting Bisco directly would provide precise details on available options.
Does the Bisco Pit and Fissure Sealant require any special storage conditions?
The data does not specify storage requirements, but as a single-use dental material, it should be stored in a clean, dry environment protected from extreme temperatures and direct light. Standard dental supply storage practices—such as refrigeration if recommended by the manufacturer—are advisable to maintain product integrity until use. Always refer to the manufacturer’s instructions for precise guidance.
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: K874556 FDA 510(k) - BISCO PIT AND FISSURE SEALANT | Bisco, Inc., BISCO PIT AND FISSURE SEALANT (K874556) — FDA 510 (k) | Innolitics, BISCO PIT AND FISSURE SEALANT 510 (k) K874556 - FDA.report, PDF K874556 - Bisco Pit and Fissure Sealant
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K874556 | Class II | Active |
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Manufacturer
- Manufacturer
- Bisco Inc.
- FDA Applicant
- Bisco, Inc.
Sources (1)
- FDA 510(k) K874556 24 fields · synced Sep 19, 2026