Cleared Traditional

K960914 - 3I OSSEOUS FIXATION SYSTEM(S)

K960914 is the FDA 510(k) clearance for 3I OSSEOUS FIXATION SYSTEM(S) by Implant Innovations, Inc.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K960914 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
29d
Days
Class 2
Risk

K960914 is an FDA 510(k) clearance for the 3I OSSEOUS FIXATION SYSTEM(S). Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Implant Innovations, Inc. (West Palm Baeach, US). The FDA issued a Cleared decision on April 4, 1996 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 Implant Innovations, Inc. devices

Submission Details

510(k) Number K960914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1996
Decision Date April 04, 1996
Days to Decision 29 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
98d faster than avg
Panel avg: 127d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K960914.
SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR
K971987 · Synthes (Usa) · Jun 1997
SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE
K964328 · Synthes (Usa) · Dec 1996
SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM
K961421 · Synthes (Usa) · Jun 1996
SYNTHES (USA) MIDFACIAL SYSTEM
K953806 · Synthes (Usa) · Mar 1996
SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM
K954385 · Synthes (Usa) · Mar 1996
LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM
K953385 · Walter Lorenz Surgical, Inc. · Sep 1995