Cleared Traditional

K940261 - LYNX LOW-SPEED HANDPIECE

K940261 is an FDA 510(k) clearance for LYNX LOW-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 342-day FDA review.

K940261 · Mti Precision Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
342d
Days
Class 1
Risk

K940261 is an FDA 510(k) clearance for the LYNX LOW-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 29, 1994 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K940261

510(k) Number K940261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date December 29, 1994
Days to Decision 342 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 128d · This submission: 342d
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 247
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K940261.
W&H 798 TOP AIR TURBINE TRIPLE SPRAY
K944717 · A-Dec, Inc. · Jun 1995
MICRO RSH HIGH SPEED HANDPIECE
K935676 · Micro Motors, Inc. · Mar 1995
DENTOOL
K923780 · Dentool, Inc. · Mar 1995
ATHENA HIGH SPEED HANDPIECE
K925678 · Athena Technology, Inc. · Dec 1994
STERI-LUBE
K942672 · Petroleum Products of America · Jul 1994
HANDPIECE MODELS: MS-350
K926154 · Dabi-Atlante America Corp. · Mar 1994
K940261 · LYNX LOW-SPEED HANDPIECE
Download PDF Mti Precision Products