Parkell Pit and Fissure Sealant
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243254 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 Parkell Pit and Fissure Sealant is a dental sealant designed to prevent dental caries by sealing the pits and fissures of molars and premolars. It is classified as a Pit and Fissure Sealant, Pit and Fissure Sealant and Conditioner, and falls under Class II medical devices according to FDA regulations. This product is intended to provide a protective barrier against bacterial penetration and acid attacks, reducing the risk of tooth decay in susceptible areas.
This sealant is supplied as a single-use product and is intended for use in dental offices by trained professionals. It is not sterile and must be prepared and applied under aseptic conditions. The device is regulated under FDA 510K clearance and complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). The product is available in various sizes and formulations, as indicated by the associated registration numbers, and is intended for application to permanent and primary teeth.
Frequently asked questions
What is the Parkell Pit and Fissure Sealant primarily used for in dental practice?
The Parkell Pit and Fissure Sealant is designed to prevent dental caries by creating a protective barrier over the pits and fissures of molars and premolars. This helps block bacterial penetration and acid attacks, reducing the risk of tooth decay in areas prone to decay. It is specifically intended for use on both permanent and primary teeth.
Is the Parkell Pit and Fissure Sealant sterile, and how should it be handled before application?
The Parkell Pit and Fissure Sealant is not sterile, so it must be prepared and applied under aseptic conditions by trained dental professionals. Since it is a single-use product, each application requires a fresh preparation to maintain safety and efficacy.
Are there multiple sizes or formulations available for the Parkell Pit and Fissure Sealant, and how can I identify them?
Yes, the Parkell Pit and Fissure Sealant comes in multiple sizes and formulations, each associated with specific registration numbers (e.g., 3038718579, 2523320, etc.). These variations allow for flexibility in clinical use, but the exact differences between formulations are not detailed in the provided data. Always verify the registration number on the packaging to confirm the correct variant for your needs.
How is the regulatory status of this device determined, and what does that mean for dental professionals?
The Parkell Pit and Fissure Sealant is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance, indicating it is deemed substantially equivalent to a legally marketed predicate device. It also complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in the EU. This means it has undergone rigorous review for safety and effectiveness, allowing dental professionals to use it with confidence in clinical settings.
Is the Parkell Pit and Fissure Sealant intended for single-use only, and what does that imply for inventory management?
Yes, the Parkell Pit and Fissure Sealant is explicitly labeled as a single-use product, meaning each application requires a new unit. This design ensures hygiene and reduces the risk of cross-contamination. For inventory management, dental offices should plan for regular restocking and avoid reusing opened or partially used sealant to maintain compliance with aseptic protocols.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243254 | Class II | Active |
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Manufacturer
- Manufacturer
- Parkell, Inc.
Sources (2)
- FDA 510(k) K243254 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026