Cleared Traditional

DEN TEK NIGHTGUARD

K063483 · Den Tek Oral Care, Inc. · Dental
Jan 2007
Decision
67d
Days
—
Risk

About This 510(k) Submission

K063483 is an FDA 510(k) clearance for the DEN TEK NIGHTGUARD, a Mouthguard, Prescription, submitted by Den Tek Oral Care, Inc. (Washington, Dc, US). The FDA issued a Cleared decision on January 23, 2007, 67 days after receiving the submission on November 17, 2006. This device falls under the Dental review panel.

Submission Details

510(k) Number K063483 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2006
Decision Date January 23, 2007
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MQC — Mouthguard, Prescription
Device Class —