Cleared Traditional

K143292 - TheraCal DC

K143292 is the FDA 510(k) clearance for TheraCal DC by Bisco, Inc.. It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 32
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K143292.
LC ResinCal PC
K202413 · S&C Polymer Silicon- Und Composite Spezialitaten GmbH · Nov 2020
Parkell Desensitizer Gel
K191103 · Parkell, Inc. · Nov 2019
TheraCal DC
K180344 · Bisco, Inc. · Apr 2018
THERACAL LC
K063237 · Bisco, Inc. · Dec 2006
BISBLOCK
K033521 · Bisco, Inc. · Jan 2004
LIFE 2
K012717 · Sybron Dental Specialties, Inc. · Oct 2001