Parkell, Inc.January 29, 2020

FDA 483 - Parkell, Inc. - January 29, 2020

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Record Details

This document is a Premarket Notification (Traditional 510(k)) submitted by Parkell, Inc. for their Self-Adhesive Cement, a Class II medical device. The submission, dated January 21, 2021, seeks clearance for a dual-component, dual-cured high-strength cement intended for various indirect dental restoratives. This is a regulatory submission and does not contain any inspectional observations or violations.

Company: Parkell, Inc.
Inspection Date: January 29, 2020
Product Type: Device
Office: Office of Medical Device and Radiological Health Operations

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ID · f0fdacb5-2a63-44a9-b6c9-000b1aaaff41