Cleared Traditional

K883842 - DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI. (FDA 510(k) Clearance)

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

K883842 · Dentsply Intl. · Dental device
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Mar 1989
Decision
186d
Days
Class 2
Risk

K883842 is an FDA 510(k) clearance for the DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on March 17, 1989 after a review of 186 days - an extended review 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: 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 Dentsply Intl. devices

Submission Details

510(k) Number K883842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1988
Decision Date March 17, 1989
Days to Decision 186 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 127d · This submission: 186d
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.

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All 401
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