ShefaBone SCPC Resorbable Bone Graft— 510(k) K153230

Name: FDA 510(k) clearance K153230
Creator: U.S. Food and Drug Administration
Published: 2016-07-14

Substantially Equivalent

The Implantech Inc./Shefabone

FDA 510(k) clearance K153230 for ShefaBone SCPC Resorbable Bone Graft, Substantially Equivalent on 2016-07-14. Applicant: The Implantech Inc./Shefabone. Device class: 2.

Clearance details

Applicant: The Implantech Inc./Shefabone
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2015-11-06
Decision date: 2016-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, 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.