P1145 Dental Restorative— 510(k) K162257

Substantially Equivalent

Kerr Corporation

FDA 510(k) clearance K162257 for P1145 Dental Restorative, Substantially Equivalent on 2016-11-07. Applicant: Kerr Corporation. Device class: 2.

Clearance details

Applicant: Kerr Corporation
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2016-08-11
Decision date: 2016-11-07
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.