SAGEMAX Z-BLANK— 510(k) K062695

Substantially Equivalent

Sagemax Bioceramics, Inc.

FDA 510(k) clearance K062695 for SAGEMAX Z-BLANK, Substantially Equivalent on 2006-10-20. 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: 2006-09-11
Decision date: 2006-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, 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.