Cleared Traditional

K010240 - POLYCARBOXYLATE (PCA) CEMENT

K010240 is an FDA 510(k) clearance for POLYCARBOXYLATE (PCA) CEMENT, manufactured by Rite-Dent Manufacturing Corp.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K010240 · Rite-Dent Manufacturing Corp. · Dental device
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Mar 2001
Decision
61d
Days
Class 2
Risk

K010240 is an FDA 510(k) clearance for the POLYCARBOXYLATE (PCA) CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Rite-Dent Manufacturing Corp. (Hialeah, US). The FDA issued a Cleared decision on March 27, 2001 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rite-Dent Manufacturing Corp. devices

FDA 510(k) Submission Details - K010240

510(k) Number K010240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2001
Decision Date March 27, 2001
Days to Decision 61 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
66d faster than avg
Panel avg: 127d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 420
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K010240.
RESIN CEM
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SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)
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DYRACT CEM LCI COMPOMER
K003921 · Dentsply Intl. · Jan 2001
CAVEX TEMPORARY CEMENT
K003791 · Cavex Holland BV · Jan 2001