Nexus Universal Self-Cure— 510(k) K191548

Substantially Equivalent

Kerr Corporation

FDA 510(k) clearance K191548 for Nexus Universal Self-Cure, Substantially Equivalent on 2019-10-11. Applicant: Kerr Corporation. Device class: 2.

Clearance details

Applicant: Kerr Corporation
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2019-06-12
Decision date: 2019-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K191548

K-number listed on FDA's recall record

Z-1824-2020 — Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to implant abutments.Class II·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·20200225

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191548.

Data sourced from openFDA. This site is unofficial and independent of the FDA.