Cleared Traditional

K973089 - FREEDOM

K973089 is the FDA 510(k) clearance for FREEDOM by Southern Dental Industries, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K973089 · Southern Dental Industries, Inc. · Dental device
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Dec 1997
Decision
112d
Days
Class 2
Risk

K973089 is an FDA 510(k) clearance for the FREEDOM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Southern Dental Industries, Inc. (San Francisco, US). The FDA issued a Cleared decision on December 8, 1997 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Southern Dental Industries, Inc. devices

Submission Details

510(k) Number K973089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1997
Decision Date December 08, 1997
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 613
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