Cleared Traditional

K001050 - CALCIJECT (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001050 · Centrix, Inc. · Dental device
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Jul 2000
Decision
112d
Days
Class 2
Risk

K001050 is an FDA 510(k) clearance for the CALCIJECT. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on July 21, 2000 after a review of 112 days - within the typical 510(k) review window.

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 Centrix, Inc. devices

Submission Details

510(k) Number K001050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2000
Decision Date July 21, 2000
Days to Decision 112 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
15d faster than avg
Panel avg: 127d · This submission: 112d
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.