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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 128d · 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 Consultant

Newton Implant Systems, Inc.
Pedro Yang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1500
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
KIS MT3
K960110 · The Implant Center of the Palm Beaches · Mar 1996
FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE
K945847 · Friatec Medical Inc., USA · Mar 1996
FRIALIT(R)-2 DENTAL IMPLANT
K945848 · Friatec Medical Inc., USA · Mar 1996
K960111 · KIS MT4
Download PDF FDA Summary The Implant Center of…