Cleared Traditional

K031010 - MIRACLE 98

K031010 is an FDA 510(k) clearance for MIRACLE 98, manufactured by Sb Lucius, Inc.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K031010 · Sb Lucius, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
86d
Days
Class 2
Risk

K031010 is an FDA 510(k) clearance for the MIRACLE 98. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Sb Lucius, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 25, 2003 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 Sb Lucius, Inc. devices

FDA 510(k) Submission Details - K031010

510(k) Number K031010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2003
Decision Date June 25, 2003
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJT Alloy, Gold-based Noble Metal

All 550
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K031010.
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ALEXANDER
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BIO UNIVERSAL
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