OptiBond eXTRa Universal— 510(k) K182162

Substantially Equivalent

Kerr Corporation

FDA 510(k) clearance K182162 for OptiBond eXTRa Universal, Substantially Equivalent on 2018-11-07. Applicant: Kerr Corporation. Device class: 2.

Clearance details

Applicant: Kerr Corporation
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2018-08-10
Decision date: 2018-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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