Seal Rite Pit and Fissure Sealant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K902022 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 Pit and Fissure Sealant is a dental device classified as a Pit And Fissure Sealant and Conditioner, designed to protect occlusal surfaces from caries. It is a resin-based material formulated to fill and seal the deep grooves and pits on molar and premolar teeth, reducing the risk of dental decay by creating a physical barrier against bacteria and acids. The device incorporates a fluoride-releasing mechanism to enhance enamel remineralization and strengthen tooth structure over time.
This product is supplied as a single-use, light-cured material in a syringe dispensing system, available in two viscosities for optimal application. It is radiopaque, allowing for radiographic identification, and intended for use in dental offices under controlled conditions. The device holds FDA 510(k) clearance (K902022) and is regulated under 21 CFR 872.3765 for dental specialty applications. Storage requires protection from light and moisture, adhering to standard dental material protocols.
Frequently asked questions
What is the primary purpose of the Seal Rite Pit and Fissure Sealant, and how does it work?
The Seal Rite Pit and Fissure Sealant is designed to protect the occlusal surfaces of molar and premolar teeth by filling and sealing deep grooves and pits. It creates a physical barrier against bacteria and acids, reducing the risk of dental decay. Additionally, it incorporates a fluoride-releasing mechanism to promote enamel remineralization and strengthen tooth structure over time.
How is the Seal Rite sealant supplied, and is it single-use or reusable?
The Seal Rite sealant is supplied as a single-use, light-cured material in a syringe dispensing system. This ensures sterility and convenience for dental offices, as each syringe is intended for one application only.
Are there different viscosities available for the Seal Rite sealant, and why?
Yes, the Seal Rite sealant is available in two viscosities. These variations are designed to optimize application, ensuring better adaptability to different pit and fissure morphologies on molar and premolar teeth for improved sealing performance.
How should the Seal Rite sealant be stored, and why is this important?
The Seal Rite sealant must be stored protected from light and moisture, following standard dental material protocols. This is critical because exposure to light or moisture can degrade the material’s properties, compromising its effectiveness as a protective sealant and potentially altering its fluoride-releasing capabilities.
What regulatory pathway does the Seal Rite sealant follow, and what does this mean for dental professionals?
The Seal Rite sealant holds FDA 510(k) clearance (K902022) and is regulated under 21 CFR 872.3765 for dental specialty applications. This means it has undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for use in dental offices under controlled conditions.
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, Pit & Fissure Sealant Archives - PULPDENT, Seal-Rite Pit & Fissure Sealant, 3 ml, 1/Pk, SEAL-3, Seal-Rite, 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 | K902022 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K902022 24 fields · synced Sep 20, 2026