Cleared Traditional

K961384 - MT-2

K961384 is an FDA 510(k) clearance for MT-2, 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.

K961384 · 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

K961384 is an FDA 510(k) clearance for the MT-2. 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 - K961384

510(k) Number K961384 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 Consultant

AllOnRx, LLC,
Erica Sanders

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 1046
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K961384.
ANGLED ABUTMENT
K962647 · Straumann USA · Oct 1996
MT1A
K961382 · The Emerging Technologies Group · Sep 1996
MT1
K961383 · The Emerging Technologies Group · Sep 1996
MT-3A
K961385 · The Emerging Technologies Group · Sep 1996
MT-2A
K961386 · The Emerging Technologies Group · Sep 1996
MT-X
K961387 · The Emerging Technologies Group · Sep 1996