Cleared Traditional

K974542 - TRUE VISION

K974542 is an FDA 510(k) clearance for TRUE VISION, manufactured by Medical Dynamics, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K974542 · Medical Dynamics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
76d
Days
Class 1
Risk

K974542 is an FDA 510(k) clearance for the TRUE VISION, TRUE VISION II. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Medical Dynamics, Inc. (Englewood, US). The FDA issued a Cleared decision on February 17, 1998 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Medical Dynamics, Inc. devices

FDA 510(k) Submission Details - K974542

510(k) Number K974542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1997
Decision Date February 17, 1998
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 66
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K974542.
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES
K983242 · Sirona Dental Systems GmbH · Dec 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
K981937 · Welch Allyn, Inc. · Aug 1998
DENTAL TRAY, STERILE, DISPOSABLE
K974238 · Trinity Laboratories, Inc. · Feb 1998
PLANMECA INTRACAM
K972033 · Planmeca Oy · Jun 1997
PROSTYLE COMPACT
K961420 · Planmeca Oy · Sep 1996