Cleared Traditional

K031439 - ALGINATE IMPRESSION MATERIAL III (FAST ...

K031439 is the FDA 510(k) clearance for ALGINATE IMPRESSION MATERIAL III (FAST ... by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K031439 · Harry J. Bosworth Co. · Dental device
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Oct 2003
Decision
149d
Days
Class 2
Risk

K031439 is an FDA 510(k) clearance for the ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR). Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on October 2, 2003 after a review of 149 days - within the typical 510(k) review window.

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: 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 Harry J. Bosworth Co. devices

Submission Details

510(k) Number K031439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2003
Decision Date October 02, 2003
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.