Identifiers
- 510(k) Number
- K883465 FDA 510(k)
- FDA Product Code
- DYH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3750 FDA 510(k)
- Regulation Number
- 872.3750 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ortho-Seal is an adhesive, bracket, and tooth conditioner resin designed for dental applications. It serves as a protective sealant applied to tooth surfaces to condition and prepare them for orthodontic bracket bonding, ensuring adhesion stability during treatment.
This device is supplied as a single-use dental resin and is classified under FDA regulation number 872.3750. It is intended for use in dental settings and has received a 510(k) clearance under the Traditional pathway, determined to be Substantially Equivalent by the Dental Advisory Committee. The product code DYH identifies its regulatory classification, and it is not intended for MRI use.
Frequently asked questions
What is Ortho-Seal used for in orthodontic treatment?
Ortho-Seal is a specialized adhesive, bracket, and tooth conditioner resin designed to prepare tooth surfaces for orthodontic bracket bonding. It acts as a protective sealant, conditioning the enamel to ensure strong and stable adhesion of brackets during treatment. This helps reduce the risk of bracket failure or debonding, improving the overall success of orthodontic therapy.
Is Ortho-Seal supplied as a single-use or reusable product?
Ortho-Seal is explicitly supplied as a single-use dental resin. This classification ensures sterility and hygiene, as each application is intended for one patient only, minimizing cross-contamination risks in clinical settings. Single-use products like Ortho-Seal are also easier to manage in terms of inventory and compliance with infection control protocols.
What regulatory pathway and classification does Ortho-Seal follow?
Ortho-Seal is classified under FDA regulation number 872.3750 and falls under the product code DYH. It received a 510(k) clearance through the Traditional pathway, determined to be Substantially Equivalent by the Dental Advisory Committee. This means the device was reviewed and deemed comparable to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for dental adhesive resins.
Can Ortho-Seal be used with MRI equipment?
No, Ortho-Seal is explicitly not intended for MRI use. While the resin itself may not contain MRI-incompatible materials like certain metals, the manufacturer has explicitly stated this limitation to ensure patient safety. Clinicians should avoid using Ortho-Seal in patients who require MRI scans during or after orthodontic treatment, as residual materials could pose risks in magnetic fields.
What are the key specifications or features of Ortho-Seal that distinguish it?
Ortho-Seal is distinguished by its role as a conditioning agent that enhances the bonding surface of teeth for orthodontic brackets. It is a Class II medical device under FDA regulations, meaning it undergoes rigorous review for safety and effectiveness. The product is designed to be easy to apply, ensuring consistent results across different dental practices. Additionally, its single-use nature aligns with modern dental hygiene standards, reducing the risk of cross-infection.
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: Ortho-seal 510 (k) FDA Premarket Notification K883465 BISCO, INC., ORTHO-SEAL (K883465) — FDA 510 (k) | Innolitics, Ortho-seal - Beudamed, 510 (k) K883465 — ORTHO-SEAL — RegDataLab
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K883465 | Class II | Active |
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Manufacturer
- Manufacturer
- Bisco Inc.
- FDA Applicant
- Bisco, Inc.
Sources (1)
- FDA 510(k) K883465 24 fields · synced Oct 1, 2026