NEXXZR(TM)T AND NEXXZR(TM)S— 510(k) K130991

Name: FDA 510(k) clearance K130991
Creator: U.S. Food and Drug Administration
Published: 2014-02-10

Substantially Equivalent

Sagemax Bioceramics, Inc.

FDA 510(k) clearance K130991 for NEXXZR(TM)T AND NEXXZR(TM)S, Substantially Equivalent on 2014-02-10. Applicant: Sagemax Bioceramics, Inc.. Device class: 2.

Clearance details

Applicant: Sagemax Bioceramics, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2013-04-10
Decision date: 2014-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Federal Way, WA, US

Download summary PDF View on FDA.gov ↗

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