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OrthoSource Etch Systems

FDA 510(k)

Class II (US FDA 510(k))

510(k) K861245

by Ortho Source

Identifiers

510(k) Number
K861245 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 OrthoSource Etch Systems are dental devices classified as Sealant, Pit and Fissure, and Conditioner, designed to prepare tooth surfaces for sealant application. These systems use acid etching to create micro-retentions on enamel, improving the adhesion and longevity of dental sealants in preventing caries.

The device is supplied as a reusable system intended for use in dental offices. It is not sterile upon delivery but is designed for single-patient use per disposable components. No MRI safety information is specified, and the system is regulated under FDA 510(k) clearance (K861245) as substantially equivalent to existing dental etchants. Storage requires adherence to manufacturer guidelines for reusable components.

Frequently asked questions

What is the primary purpose of the OrthoSource Etch Systems in dental procedures?

The OrthoSource Etch Systems are designed to prepare tooth surfaces for sealant application by using acid etching. This process creates micro-retentions on the enamel, which enhances the adhesion and longevity of dental sealants, helping to prevent cavities (caries) in the treated areas.

Are the OrthoSource Etch Systems intended for single-use or reusable applications?

The system itself is reusable, but it is designed for single-patient use per disposable components. This ensures hygiene and compliance with clinical protocols, as the reusable parts are not meant to be sterilized between patients.

How should the reusable components of the OrthoSource Etch Systems be stored?

The reusable components of the OrthoSource Etch Systems must be stored according to the manufacturer’s guidelines. Since they are not sterile upon delivery and are intended for single-patient use with disposable parts, proper storage is critical to maintain their functionality and prevent contamination.

What regulatory pathway was followed for the OrthoSource Etch Systems?

The OrthoSource Etch Systems were cleared through the FDA’s 510(k) process, specifically under the Traditional pathway, and were determined to be substantially equivalent to existing dental etchants. The clearance number is K861245, and the device falls 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: Orthosource dental products and supplies | Pearson Dental, Orthodontic and Dental Supplies - OrthoSourceOnline, OrthoSourceOnline.Com - Orthodontic and Dental Products and Supplies ..., ORTHOSOURCE Products - Pearson Dental Supplies, OrthoSourceGlobal - High Quality Orthodontic, Dental Products, USA Made ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ortho Source

Sources (1)

  • FDA 510(k) K861245 24 fields · synced Sep 19, 2026