Cleared Traditional

K061122 - NIGHT GUARD

K061122 · Alpine Oral Care, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
322d
Days
-
Risk

K061122 is an FDA 510(k) clearance for the NIGHT GUARD. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Alpine Oral Care, LLC (Houston, US). The FDA issued a Cleared decision on March 12, 2007 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K061122

510(k) Number K061122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2006
Decision Date March 12, 2007
Days to Decision 322 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 128d · This submission: 322d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 71
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K061122.
GRINDGUARD
K082723 · Grind Guard Technologies, LLC · Aug 2009
THERMOFORM SHEET MATERIALS AND ACCESSORIES
K072522 · Dentsply International, Inc. · Nov 2007
SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE
K071404 · Power Products, Inc.-Splintek · Aug 2007
DEN TEK NIGHTGUARD
K063483 · Den Tek Oral Care, Inc. · Jan 2007
MOUTHGUARD AND ALIGNER MATERIALS
K062828 · Dentsply Intl., Inc. · Nov 2006
DOCTOR'S NIGHTGUARD
K053580 · Dental Concepts, LLC · Mar 2006
K061122 · NIGHT GUARD
Download PDF FDA Summary Alpine Oral Care, LLC