Cleared Traditional

K961631 - ODONT HEX SYSTEM

K961631 is an FDA 510(k) clearance for ODONT HEX SYSTEM, manufactured by Odontit S.A.. The device is a Class 2 Dental device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K961631

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
250d slower than avg
Panel avg: 128d · This submission: 378d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

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 1510
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K961631.
SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
K970752 · Sulzer Calcitek, Inc. · Jun 1997
LIFECORE O-RING ABUTMENT
K970776 · Lifecore Biomedical, Inc. · May 1997
KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)
K962753 · Biomedical Implant Technology, Inc. · May 1997
ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K971196 · Innova Corp. · May 1997
MINIMATIC VARIOUS IMPLANT SYSTEMS
K952905 · Minimatic, Inc. · Apr 1997
LEIBINGER IMF SCREW
K963030 · Howmedica Leibinger, Inc. · Apr 1997
K961631 · ODONT HEX SYSTEM
Download PDF FDA Summary Odontit S.A.