Ready-Fit— 510(k) K151149

Substantially Equivalent

Den Tek Oral Care, Inc.

FDA 510(k) clearance K151149 for Ready-Fit, Substantially Equivalent on 2015-09-30. Applicant: Den Tek Oral Care, Inc.. Device class: Unclassified.

Clearance details

Applicant: Den Tek Oral Care, Inc.
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2015-04-30
Decision date: 2015-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maryville, TN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Den Tek Oral Care, Inc.

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K091660 — CUSTOM COMFORT NIGHTGUARD VERSION 22009-06-12
K083400 — CUSTOM COMFORT NIGHTGUARD2008-12-11
K081669 — IMPROVED COMFORT-FIT NIGHTGUARD2008-07-10

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