Cleared Traditional

K961381 - KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS

K961381 is an FDA 510(k) clearance for KIS-III NON-SUBMERGED IMPLANT, manufactured by The Emerging Technologies Group. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 539-day FDA review.

K961381 · The Emerging Technologies Group · Dental device
Download Printable Device Report (PDF)
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Sep 1997
Decision
539d
Days
Class 2
Risk

K961381 is an FDA 510(k) clearance for the KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by The Emerging Technologies Group (N. Palm Beach, US). The FDA issued a Cleared decision on September 9, 1997 after a review of 539 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all The Emerging Technologies Group devices

FDA 510(k) Submission Details - K961381

510(k) Number K961381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1996
Decision Date September 09, 1997
Days to Decision 539 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
412d slower than avg
Panel avg: 127d · This submission: 539d
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 1046
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K961381.
THE MAESTRO SYSTEM
K972313 · BioHorizons Implant Systems, Inc. · Sep 1997
QUICK COUPLING DEVICE FOR DENTAL PROSTHESES
K950260 · Dr. Joseph E. Grasso, D.D.S. · Sep 1997
DEVICE FOR PROVIDING QUICK COUPLING FOR DENTAL PROSTHESES
K950261 · Dr. Joseph E. Grasso, D.D.S. · Sep 1997
3I INNOVATIVE IMPLANTS AND COVER SCREWS
K972444 · Implant Innovations, Inc. · Aug 1997
THE PERIOSEAL DENTAL IMPLANT
K965032 · Perioseal · Aug 1997
ROOTFORM DENTAL IMPLANT SYSTEM
K954758 · Swiss Dental Center · Aug 1997