DIBS (Digital Indirect Bonding System)— 510(k) K192701

Name: FDA 510(k) clearance K192701
Creator: U.S. Food and Drug Administration
Published: 2020-04-21

Substantially Equivalent

Orthoselect, LLC

FDA 510(k) clearance K192701 for DIBS (Digital Indirect Bonding System), Substantially Equivalent on 2020-04-21. Applicant: Orthoselect, LLC. Device class: 2.

Clearance details

Applicant: Orthoselect, LLC
Product code: Code PNN
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2019-09-27
Decision date: 2020-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: American Fork, UT, 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.