Dentin Disclosing Gel and Gel Remover
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K896658 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dentin Disclosing Gel and Gel Remover is a dental device designed for identifying and removing residual disclosing gel from teeth. It falls under the classification of materials used for tooth shade assessment and resin applications in dental procedures.
This device is supplied as a dual-component system for application and removal of disclosing gel, intended for use in dental offices. It is classified as a Class II device under FDA regulations and has received a 510(k) clearance with the decision code SESE (Substantially Equivalent). The product is intended for single-use and adheres to dental hygiene standards for patient care.
Frequently asked questions
What is the Dentin Disclosing Gel and Gel Remover used for in a dental setting?
This device is specifically designed to help dentists identify any residual disclosing gel on teeth after procedures. The dual-component system allows for application of the disclosing gel to reveal areas that may have missed cleaning or treatment, followed by its removal using the accompanying gel remover. It’s particularly useful in ensuring thorough dental hygiene before resin applications or shade assessments.
Is the Dentin Disclosing Gel and Gel Remover intended for single-use or can it be reused?
The device is explicitly labeled for single-use only, aligning with dental hygiene standards to prevent cross-contamination and ensure patient safety. Reusing it could compromise sterility and effectiveness, so each application requires a fresh set.
How is the Dentin Disclosing Gel and Gel Remover supplied, and what does the dual-component system include?
The product is supplied as a two-part system for dental offices: one component is the dentin disclosing gel (for application to teeth), and the other is the gel remover (to safely eliminate the disclosing agent afterward). Both are packaged together as a single-use kit, ensuring convenience and proper workflow integration.
What regulatory pathway did the Dentin Disclosing Gel and Gel Remover follow to gain market authorization?
The device received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device with a Substantially Equivalent (SESE) determination by the Dental (DE) Advisory Committee. This means it was deemed comparable to a legally marketed predicate device, ensuring compliance with dental materials standards before approval.
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: Dentin Disclosing Gel and Gel Remover - Beudamed, DENTIN DISCLOSING GEL AND GEL REMOVER 510 (k) K896658 - FDA.report, 510(k) K896658 — DENTIN DISCLOSING GEL AND GEL REMOVER - RegDataLab, Pulpdent Dentin Disclosing Gel And Gel Remover - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K896658 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K896658 24 fields · synced Sep 18, 2026