Cleared Traditional

K961631 - ODONT HEX SYSTEM

K961631 is the FDA 510(k) clearance for ODONT HEX SYSTEM by Odontit S.A.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K961631 · Odontit S.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
378d
Days
Class 2
Risk

K961631 is an FDA 510(k) clearance for the ODONT HEX SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Odontit S.A. (Buenos Aires, AR). The FDA issued a Cleared decision on May 12, 1997 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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. Elevated predicate reliance profile. 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 Odontit S.A. devices

Submission Details

510(k) Number K961631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1996
Decision Date May 12, 1997
Days to Decision 378 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
251d slower than avg
Panel avg: 127d · This submission: 378d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 345
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K961631.
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