Cleared Traditional

K143292 - TheraCal DC

K143292 is an FDA 510(k) clearance for TheraCal DC, manufactured by Bisco, Inc.. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K143292 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
260d
Days
Class 2
Risk

K143292 is an FDA 510(k) clearance for the TheraCal DC. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 4, 2015 after a review of 260 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - 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 Bisco, Inc. devices

FDA 510(k) Submission Details - K143292

510(k) Number K143292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2014
Decision Date August 04, 2015
Days to Decision 260 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 127d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJK Device Classification - Class 2, Special Controls

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJK Liner, Cavity, Calcium Hydroxide

All 54
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K143292.
LC ResinCal PC
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BASE IT
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K131068 · Kuraray Noritake Dental, Inc. · Aug 2013
TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID
K122421 · Kuraray Noritake Dental, Inc. · Dec 2012