Cleared Traditional

K003427 - ZINC PHOSPHATE CEMENT

K003427 is an FDA 510(k) clearance for ZINC PHOSPHATE 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 82-day FDA review.

K003427 · Rite-Dent Manufacturing Corp. · Dental device
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Jan 2001
Decision
82d
Days
Class 2
Risk

K003427 is an FDA 510(k) clearance for the ZINC PHOSPHATE 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 January 24, 2001 after a review of 82 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 - K003427

510(k) Number K003427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2000
Decision Date January 24, 2001
Days to Decision 82 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
45d faster than avg
Panel avg: 127d · This submission: 82d
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 K003427.
ONE-STEP PLUS
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K003407 · Ivoclar North America, Inc. · Jan 2001
DYRACT CEM LCI COMPOMER
K003921 · Dentsply Intl. · Jan 2001
CAVEX TEMPORARY CEMENT
K003791 · Cavex Holland BV · Jan 2001
TEMP-BOND NE 2
K003658 · Sybron Dental Specialties, Inc. · Jan 2001