Cleared Traditional

K895736 - LYNX-HIGH SPEED HANDPIECE

K895736 is an FDA 510(k) clearance for LYNX-HIGH SPEED HANDPIECE, manufactured by Mti Precision Products. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K895736 · Mti Precision Products · Dental device
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Dec 1989
Decision
83d
Days
Class 1
Risk

K895736 is an FDA 510(k) clearance for the LYNX-HIGH SPEED HANDPIECE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Mti Precision Products (Lakewood, US). The FDA issued a Cleared decision on December 18, 1989 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Mti Precision Products devices

FDA 510(k) Submission Details - K895736

510(k) Number K895736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1989
Decision Date December 18, 1989
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 138
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K895736.
OSTEOMED IB DRILL
K911937 · Osteomed Corp. · Jun 1991
DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
K900093 · Dentsply Intl. · Apr 1990
DISPOSABLE PROPHY ANGLE AND ACCESSORIES
K897101 · Dentsply Intl. · Mar 1990
MICRO-AIRE HIGH SPEED DRILL (2910-000)
K894606 · Micro-Aire Surgical Instruments, Inc. · Oct 1989
PLAQUE-SWEEP
K873209 · Dentsply Intl. · Aug 1987
TUBING HANDPIECE REPLACEMENT
K854697 · Almore Intl., Inc. · Mar 1986