Cleared Traditional

K945815 - DENTAL KIT

K945815 is an FDA 510(k) clearance for DENTAL KIT, manufactured by Constancy Ent., Inc.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K945815 · Constancy Ent., Inc. · Dental device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K945815

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.

EKJ Device Classification - Class 1, General Controls

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

All 23
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K945815.
ASEPTYLUM, UNI-CARRIER
K961714 · Distriflor S.A. · Jun 1996
MEDTROL DENTAL KIT
K953707 · Medtrol, Inc. · Jan 1996
SUREFLEX FILES
K951607 · Dentsply Intl. · Jun 1995
PRESTERILIZED ENDODONTIC FILES
K943584 · Dentsply Intl. · Sep 1994
AMD DENTIST AND HYGIENIST KITS
K925115 · Advance Medical Designs, Inc. · Jul 1994
APPLICATOR NOZZLE
K926368 · Centrix, Inc. · Sep 1993