CUSTOM COMFORT NIGHTGUARD— 510(k) K083400

Name: FDA 510(k) clearance K083400
Creator: U.S. Food and Drug Administration
Published: 2008-12-11

Substantially Equivalent

Den Tek Oral Care, Inc.

FDA 510(k) clearance K083400 for CUSTOM COMFORT NIGHTGUARD, Substantially Equivalent on 2008-12-11. 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: 2008-11-17
Decision date: 2008-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Den Tek Oral Care, Inc.

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K151149 — Ready-Fit2015-09-30
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K123849 — NEW COMFORT-FIT DENTAL GUARD2013-01-10
K091660 — CUSTOM COMFORT NIGHTGUARD VERSION 22009-06-12
K081669 — IMPROVED COMFORT-FIT NIGHTGUARD2008-07-10

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