Identifiers
- 510(k) Number
- K911287 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 by sealing enamel pits and fissures. It is a resin-based material formulated to adhere to tooth surfaces, reducing the risk of dental decay in susceptible areas.
This device is supplied as a single-use, non-sterile product in syringe form, intended for use in dental offices. It is radiopaque, allowing for visibility under X-ray imaging, and is available in multiple viscosities. The Seal-Rite Pit and Fissure Sealant received FDA 510K clearance under the Traditional pathway, classified as a Class II medical device (regulation number 872.3765). Storage and handling follow standard dental material protocols.
Frequently asked questions
What is the primary purpose of the Pulpdent Seal-Rite Pit and Fissure Sealant, and how does it work?
The Pulpdent Seal-Rite Pit and Fissure Sealant is designed to protect occlusal surfaces of teeth from dental caries by sealing enamel pits and fissures. It works as a resin-based material that adheres to tooth surfaces, creating a physical barrier that reduces the risk of decay in areas prone to bacterial accumulation and acid attacks.
Is the Seal-Rite Pit and Fissure Sealant available in multiple viscosities, and why might that matter?
Yes, the Seal-Rite Pit and Fissure Sealant is available in multiple viscosities, which allows clinicians to choose the consistency best suited for different patient needs or anatomical variations. Higher viscosities may provide better flow control for deeper fissures, while lower viscosities might be easier to apply to smoother surfaces, ensuring optimal coverage and adhesion.
How is the Seal-Rite supplied, and is it intended for single-use only?
The Seal-Rite Pit and Fissure Sealant is supplied as a single-use, non-sterile product in syringe form, specifically for use in dental offices. The single-use design ensures hygiene and prevents cross-contamination between patients, which is critical in clinical settings where sterility is paramount.
Can the Seal-Rite be visualized under X-ray imaging, and what clinical benefit does this provide?
Yes, the Seal-Rite Pit and Fissure Sealant is radiopaque, meaning it can be visualized under X-ray imaging. This feature allows clinicians to confirm proper placement and coverage of the sealant, ensuring that high-risk areas are effectively protected against caries and verifying that the material has been applied correctly.
What storage and handling guidelines should be followed for the Seal-Rite Pit and Fissure Sealant?
The Seal-Rite should be stored and handled according to standard dental material protocols, though specific details like temperature or shelf-life are not provided in the data. Since it is non-sterile and single-use, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity until use.
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, Seal-Rite™ (Pulpdent) | Dental Product | Pearson Dental, Seal-Rite Pit & Fissure Sealant, 3 ml, 1/Pk, SEAL-3, Seal-Rite Pit and Fissure Sealant - Prime Dental Supply, SEAL-RITE | Pulpdent Corporation | DPS - Dental Product Shopper
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K911287 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K911287 24 fields · synced Sep 18, 2026