Cleared Traditional

K961385 - MT-3A

K961385 is an FDA 510(k) clearance for MT-3A, 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 190-day FDA review.

K961385 · The Emerging Technologies Group · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
190d
Days
Class 2
Risk

K961385 is an FDA 510(k) clearance for the MT-3A. 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 25, 1996 after a review of 190 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all The Emerging Technologies Group devices

FDA 510(k) Submission Details - K961385

510(k) Number K961385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1996
Decision Date September 25, 1996
Days to Decision 190 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
63d slower than avg
Panel avg: 127d · This submission: 190d
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 K961385.
MT1A
K961382 · The Emerging Technologies Group · Sep 1996
MT1
K961383 · The Emerging Technologies Group · Sep 1996
MT-2
K961384 · The Emerging Technologies Group · Sep 1996
MT-2A
K961386 · The Emerging Technologies Group · Sep 1996
MT-X
K961387 · The Emerging Technologies Group · Sep 1996
TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS
K962465 · Implant Innovations, Inc. · Sep 1996