Cleared Traditional

LYNX LOW-SPEED HANDPIECE (K900798) - FDA 510(k) Clearance

Class I Dental device.

K900798 · Air Motors Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
127d
Days
Class 1
Risk

K900798 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 Air Motors Technologies (Shelomi, IL). The FDA issued a Cleared decision on June 27, 1990 after a review of 127 days - within the typical 510(k) review window.

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. 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 Air Motors Technologies devices

Submission Details

510(k) Number K900798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1990
Decision Date June 27, 1990
Days to Decision 127 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 127d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 37
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K900798.
ESTYLUS ELECTRIC MOTOR SYSTEM
K031145 · Dentsply Intl. · Jul 2003
TULSA CONTRA ANGLES
K012720 · Dentsply Intl. · Nov 2001
RAPIDD HIGHSPEED DENTAL HANDPIECE
K003518 · Dentsply Intl. · Jan 2001
DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
K900093 · Dentsply Intl. · Apr 1990
DISPOSABLE PROPHY ANGLE AND ACCESSORIES
K897101 · Dentsply Intl. · Mar 1990
PLAQUE-SWEEP
K873209 · Dentsply Intl. · Aug 1987