ETCH GEL— 510(k) K131248

Substantially Equivalent

Dmg America, LLC

FDA 510(k) clearance K131248 for ETCH GEL, Substantially Equivalent on 2013-07-11. Applicant: Dmg America, LLC. Device class: 2.

Clearance details

Applicant: Dmg America, LLC
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2013-05-01
Decision date: 2013-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ayer, 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.