Cleared Traditional

K073243 - LED PRO SEAL

K073243 is the FDA 510(k) clearance for LED PRO SEAL by Reliance Orthodontic Products, Inc.. It is a Class 2 Dental device (product code EBD) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K073243 · Reliance Orthodontic Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
81d
Days
Class 2
Risk

K073243 is an FDA 510(k) clearance for the LED PRO SEAL. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Reliance Orthodontic Products, Inc. (Itasca, US). The FDA issued a Cleared decision on February 8, 2008 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Reliance Orthodontic Products, Inc. devices

Submission Details

510(k) Number K073243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2007
Decision Date February 08, 2008
Days to Decision 81 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
46d faster than avg
Panel avg: 127d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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.

Regulatory Peers - EBD Coating, Filling Material, Resin

All 33
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K073243.
OPTIGLAZE COLOR
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G-COAT
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BISCOVER LED
K051999 · Bisco, Inc. · Aug 2005