Cleared Traditional

K792363 - SILAGUM

K792363 is the FDA 510(k) clearance for SILAGUM by Parkell, Inc.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K792363 · Parkell, Inc. · Dental device
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Jan 1980
Decision
47d
Days
Class 2
Risk

K792363 is an FDA 510(k) clearance for the SILAGUM. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Parkell, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1980 after a review of 47 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 Parkell, Inc. devices

Submission Details

510(k) Number K792363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1979
Decision Date January 09, 1980
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 127d · This submission: 47d
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.

Regulatory Peers - ELW Material, Impression

All 140
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K792363.
ASH BLUEPRINT ALGINATE IMPRESSION MATER.
K801587 · Dentsply Intl. · Jul 1980
VINYL POLYSILOXANE IMPRESSION MATERIAL
K800485 · 3M Company · Mar 1980
SUPERSIL
K800548 · Harry J. Bosworth Co. · Mar 1980
ZYLOX
K782139 · Premier Dental Products Co. · Feb 1979
REPROSIL
K781151 · Dentsply Intl. · Aug 1978
PERMAGUM ADHESIVE
K771853 · Espe GmbH (Us) · Oct 1977