Zipbond— 510(k) K191656

Substantially Equivalent

Sdi Limited

FDA 510(k) clearance K191656 for Zipbond, Substantially Equivalent on 2019-12-02. Applicant: Sdi Limited. Device class: 2.

Clearance details

Applicant: Sdi Limited
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2019-06-21
Decision date: 2019-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bayswater, AU

Download summary PDF View on FDA.gov ↗

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