CUSTOM COMFORT NIGHTGUARD VERSION 2— 510(k) K091660

Name: FDA 510(k) clearance K091660
Creator: U.S. Food and Drug Administration
Published: 2009-06-12

Substantially Equivalent

Den Tek Oral Care, Inc.

FDA 510(k) clearance K091660 for CUSTOM COMFORT NIGHTGUARD VERSION 2, Substantially Equivalent on 2009-06-12. 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: 2009-06-09
Decision date: 2009-06-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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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.