DEN TEK COMFORT FIT NIGHTGUARD— 510(k) K072147

Name: FDA 510(k) clearance K072147
Creator: U.S. Food and Drug Administration
Published: 2007-08-30

Substantially Equivalent

Den Tek Oral Care, Inc.

FDA 510(k) clearance K072147 for DEN TEK COMFORT FIT NIGHTGUARD, Substantially Equivalent on 2007-08-30. 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: 2007-08-03
Decision date: 2007-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBR

view all

K260790 — G-Series Grind Guard2026-06-25
K252485 — ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))2026-04-10
K253641 — Owl Night Guard2026-02-26
K252004 — enCore Night Guard2025-11-25
K251778 — Remi Custom Night Guard2025-10-17

More clearances from Den Tek Oral Care, Inc.

view all

K151149 — Ready-Fit2015-09-30
K130186 — DENTEK EASY BRUSH WITH FLUORIDE2013-07-15
K123849 — NEW COMFORT-FIT DENTAL GUARD2013-01-10
K091660 — CUSTOM COMFORT NIGHTGUARD VERSION 22009-06-12
K083400 — CUSTOM COMFORT NIGHTGUARD2008-12-11

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