Cleared Traditional

K102526 - BLO2X OXYGEN BLOCKER

K102526 is an FDA 510(k) clearance for BLO2X OXYGEN BLOCKER, manufactured by Pascal Co., Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K102526 · Pascal Co., Inc. · Dental device
Download Printable Device Report (PDF)
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Oct 2010
Decision
50d
Days
Class 2
Risk

K102526 is an FDA 510(k) clearance for the BLO2X OXYGEN BLOCKER. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pascal Co., Inc. (Bellevue, US). The FDA issued a Cleared decision on October 22, 2010 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory framework. 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 Pascal Co., Inc. devices

FDA 510(k) Submission Details - K102526

510(k) Number K102526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2010
Decision Date October 22, 2010
Days to Decision 50 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 127d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.