Identifiers
- 510(k) Number
- K902023 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 Procedure Kit is a dental device classified as a Pit and Fissure Sealant, and Conditioner (OpenFDA: EBC, Regulation Number 872.3765). It is designed to protect dental enamel from caries by sealing the occlusal surfaces of teeth, particularly in the deep grooves and fissures where bacteria and food particles can accumulate. The kit includes materials for etching, rinsing, and applying a fluoride-releasing, light-cured resin sealant to prevent tooth decay in pediatric and adult patients.
This single-use, non-sterile kit is intended for use in dental offices and clinics. It contains components for preparing the tooth surface (etchant, rinse) and applying the sealant, which requires light activation for polymerization. The kit is not MRI-compatible and is supplied as a complete procedure set for one application. Authorized under FDA 510K clearance (K902023), the Seal-Rite Procedure Kit adheres to dental regulatory standards for Class II devices and is distributed in the United States.
Frequently asked questions
What is the Seal-Rite Procedure Kit specifically designed to protect against, and who is it intended for?
The Seal-Rite Procedure Kit is designed to protect dental enamel from caries (tooth decay) by sealing the occlusal surfaces of teeth, particularly in deep grooves and fissures where bacteria and food particles can accumulate. It is intended for use in pediatric and adult patients to prevent tooth decay. The kit includes materials for etching, rinsing, and applying a fluoride-releasing, light-cured resin sealant.
Is the Seal-Rite Procedure Kit sterile, and how many times can it be used?
The Seal-Rite Procedure Kit is non-sterile and is intended for single-use only. Each kit is supplied as a complete procedure set for one application, ensuring it remains uncontaminated for a single dental procedure.
Does the Seal-Rite Procedure Kit require any special equipment or activation for the sealant to work?
Yes, the Seal-Rite Procedure Kit requires light activation for polymerization of the sealant. This means a dental curing light must be used to harden the resin sealant after it is applied to the tooth surface.
How should the Seal-Rite Procedure Kit be stored, and what is its intended use environment?
The Seal-Rite Procedure Kit is intended for use in dental offices and clinics. While specific storage instructions are not detailed in the data, typical single-use dental kits like this should be stored in a clean, dry environment, away from direct sunlight and extreme temperatures, to maintain the integrity of the components until use.
What regulatory pathway was followed for the approval of the Seal-Rite Procedure Kit, and what class is it assigned?
The Seal-Rite Procedure Kit was cleared through the FDA’s 510(k) pathway, specifically under Traditional clearance, and is classified as a Class II medical device. It was determined to be substantially equivalent to a predicate device and is authorized for use in the United States under the product code EBC.
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, Pulpdent - Seal-Rite Procedure Kit Pulpdent - Seal-Rite Procedure Kit ..., Seal-Rite, Procedure Kit, RITE | Pulpdent | Darby Dental, Seal-Rite™ (Pulpdent) | Dental Product | Pearson Dental, Seal-Rite Procedure Kit - dentalwholesaledirect.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K902023 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K902023 24 fields · synced Sep 18, 2026