Cleared Traditional

K003426 - ALGINATE IMPRESSION MATERIAL

K003426 is an FDA 510(k) clearance for ALGINATE IMPRESSION MATERIAL, manufactured by Rite-Dent Manufacturing Corp.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K003426 · Rite-Dent Manufacturing Corp. · Dental device
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Jan 2001
Decision
81d
Days
Class 2
Risk

K003426 is an FDA 510(k) clearance for the ALGINATE IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Rite-Dent Manufacturing Corp. (Hialeah, US). The FDA issued a Cleared decision on January 23, 2001 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 - K003426

510(k) Number K003426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2000
Decision Date January 23, 2001
Days to Decision 81 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
46d faster than avg
Panel avg: 127d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 305
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K003426.
TAKE 1
K003808 · Sybron Dental Specialties, Inc. · Mar 2001
PERMLASTIC 3
K003650 · Sybron Dental Specialties, Inc. · Feb 2001
FLEXTIME MAGNUM 360
K003930 · Heraeus Kulzer, Inc. · Feb 2001
TAKE 1 BITE
K001876 · Sybron Dental Specialties, Inc. · Jul 2000
CORRECT PLUS
K001218 · Jeneric/Pentron, Inc. · Jul 2000
KROM-ALGINATE AND ALGINATE PLUS
K000686 · Cavex Holland BV · May 2000