Cleared Traditional

STAT PAK (K943820) - FDA 510(k) Clearance

Class I Dental device.

K943820 · Magnum Instruments, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
89d
Days
Class 1
Risk

K943820 is an FDA 510(k) clearance for the STAT PAK. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Magnum Instruments, Inc. (Glendale Heights, US). The FDA issued a Cleared decision on November 2, 1994 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Magnum Instruments, Inc. devices

Submission Details

510(k) Number K943820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1994
Decision Date November 02, 1994
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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 - EKJ Burnisher, Operative

Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K943820.
SUREFLEX FILES
K951607 · Dentsply Intl. · Jun 1995
PRESTERILIZED ENDODONTIC FILES
K943584 · Dentsply Intl. · Sep 1994
VITRABOND LIGHT CURE GLASS IONOMER LINER
K882821 · 3M Company · Sep 1988
DENTALVISION TV SYSTEM
K880542 · Dentsply Intl. · May 1988
DISPOSABLE DENTAL PROBE/EXPLORER
K880590 · Baxter Healthcare Corp · Mar 1988