MAXCEM 2— 510(k) K073209

Substantially Equivalent

Kerr Corporation

FDA 510(k) clearance K073209 for MAXCEM 2, Substantially Equivalent on 2008-01-29. Applicant: Kerr Corporation. Device class: 2.

Clearance details

Applicant: Kerr Corporation
Product code: Code MZW
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2007-11-14
Decision date: 2008-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K073209

K-number listed on FDA's recall record

Z-1076-2013 — Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.Class II·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·20130222

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073209.

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