Cleared Traditional

DENTAL KIT (K945815) - FDA 510(k) Clearance

Class I Dental device.

K945815 · Constancy Ent., Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Jul 1995
Decision
233d
Days
Class 1
Risk

K945815 is an FDA 510(k) clearance for the DENTAL KIT. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Constancy Ent., Inc. (San Gabriel, US). The FDA issued a Cleared decision on July 19, 1995 after a review of 233 days - an extended review 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: 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 Constancy Ent., Inc. devices

Submission Details

510(k) Number K945815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1994
Decision Date July 19, 1995
Days to Decision 233 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
106d slower than avg
Panel avg: 127d · This submission: 233d
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 K945815.
SUREFLEX FILES
K951607 · Dentsply Intl. · Jun 1995
PRESTERILIZED ENDODONTIC FILES
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K882821 · 3M Company · Sep 1988
DENTALVISION TV SYSTEM
K880542 · Dentsply Intl. · May 1988
DISPOSABLE DENTAL PROBE/EXPLORER
K880590 · Baxter Healthcare Corp · Mar 1988