Cleared Traditional

K960026 - BIOHORIZONS DENTAL IMPLANT SYSTEM

K960026 is an FDA 510(k) clearance for BIOHORIZONS DENTAL IMPLANT SYSTEM, manufactured by BioHorizons Implant Systems, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K960026 · BioHorizons Implant Systems, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
86d
Days
Class 2
Risk

K960026 is an FDA 510(k) clearance for the BIOHORIZONS DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by BioHorizons Implant Systems, Inc. (Birmingham, US). The FDA issued a Cleared decision on March 28, 1996 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K960026

510(k) Number K960026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1996
Decision Date March 28, 1996
Days to Decision 86 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
42d faster than avg
Panel avg: 128d · This submission: 86d
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 1424
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K960026.
OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW
K955332 · Opti-Max · May 1996
SARGON IMMEDIATE LOAD IMPLANT
K961005 · Graham & James · May 1996
3I STANDARD THREADED IMPLANT
K954347 · Implant Innovations, Inc. · Apr 1996
HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K960288 · Lifecore Biomedical, Inc. · Mar 1996
KIS MT4
K960111 · The Implant Center of the Palm Beaches · Mar 1996
KIS MT3
K960110 · The Implant Center of the Palm Beaches · Mar 1996