Cleared Traditional

K960111 - KIS MT4

K960111 is an FDA 510(k) clearance for KIS MT4, manufactured by The Implant Center of the Palm Beaches. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K960111 · The Implant Center of the Palm Beaches · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
76d
Days
Class 2
Risk

K960111 is an FDA 510(k) clearance for the KIS MT4. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by The Implant Center of the Palm Beaches (N. Palm Beach, US). The FDA issued a Cleared decision on March 27, 1996 after a review of 76 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.

View all The Implant Center of the Palm Beaches devices

FDA 510(k) Submission Details - K960111

510(k) Number K960111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date March 27, 1996
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
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 941
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K960111.
3I STANDARD THREADED IMPLANT
K954347 · Implant Innovations, Inc. · Apr 1996
BIOHORIZONS DENTAL IMPLANT SYSTEM
K960026 · BioHorizons Implant Systems, Inc. · Mar 1996
HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K960288 · Lifecore Biomedical, Inc. · Mar 1996
5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS
K955619 · Calcitek, Inc. · Mar 1996
INTERPORE THREADED IMPLANT
K960371 · Interpore Intl. · Mar 1996
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K954512 · Lifecore Biomedical, Inc. · Feb 1996