OBA-MCP, Orthodontic Bracket Adhesive with MCP— 510(k) K173020

Name: FDA 510(k) clearance K173020
Creator: U.S. Food and Drug Administration
Published: 2018-01-17

Substantially Equivalent

Pulpdent Corporation

FDA 510(k) clearance K173020 for OBA-MCP, Orthodontic Bracket Adhesive with MCP, Substantially Equivalent on 2018-01-17. Applicant: Pulpdent Corporation. Device class: 2.

Clearance details

Applicant: Pulpdent Corporation
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2017-09-28
Decision date: 2018-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, 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.