Cleared Traditional

K072522 - THERMOFORM SHEET MATERIALS AND ACCESSORIES

K072522 · Dentsply International, Inc. · Dental device
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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.

View all Dentsply International, Inc. devices

Submission Details

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
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -