Cleared Traditional

K072522 - THERMOFORM SHEET MATERIALS AND ACCESSORIES

K072522 · Dentsply International, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
70d
Days
-
Risk

K072522 is an FDA 510(k) clearance for the THERMOFORM SHEET MATERIALS AND ACCESSORIES. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on November 16, 2007 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K072522

510(k) Number K072522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2007
Decision Date November 16, 2007
Days to Decision 70 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
58d faster than avg
Panel avg: 128d · This submission: 70d
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 K072522.
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K071404 · Power Products, Inc.-Splintek · Aug 2007
NIGHT GUARD
K061122 · Alpine Oral Care, LLC · Mar 2007
DEN TEK NIGHTGUARD
K063483 · Den Tek Oral Care, Inc. · Jan 2007
K072522 · THERMOFORM SHEET MATERIALS AND ACCESSORIES
Download PDF FDA Summary Dentsply Internationa…