Cleared Traditional

K960541 - LYNX DPA DISPOSABLE PROPHY ANGLE

K960541 is an FDA 510(k) clearance for LYNX DPA DISPOSABLE PROPHY ANGLE, 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 50-day FDA review.

K960541 · Mti Precision Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
50d
Days
Class 1
Risk

K960541 is an FDA 510(k) clearance for the LYNX DPA DISPOSABLE PROPHY ANGLE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Mti Precision Products (West Cadwell, US). The FDA issued a Cleared decision on March 28, 1996 after a review of 50 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 - K960541

510(k) Number K960541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1996
Decision Date March 28, 1996
Days to Decision 50 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
77d faster than avg
Panel avg: 127d · This submission: 50d
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 137
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K960541.
IMPACT AIR 45 4-HOLE
K952927 · Palisades Pharmaceutics, Inc. · Aug 1996
MM 324
K961076 · Micro-Mega Societe Anonyme · Apr 1996
LARES RESEARCH AS-1 LOWSPEED HANDPIECE
K961163 · Lares Research, Inc. · Apr 1996
MIDWEST ONE
K955655 · Midwest Dental Products Corp. · Mar 1996
ALLRAP/SLIP-N-GRIP
K960352 · Dental Disposables Intl., Inc. · Feb 1996
SHORTSTOP DISPOSABLE PROPHY ANGLE
K955654 · Spintech, Inc. · Feb 1996