Cleared Traditional

K800548 - SUPERSIL

K800548 is the FDA 510(k) clearance for SUPERSIL by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K800548 · Harry J. Bosworth Co. · Dental device
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Mar 1980
Decision
8d
Days
Class 2
Risk

K800548 is an FDA 510(k) clearance for the SUPERSIL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Mchenry, US). The FDA issued a Cleared decision on March 18, 1980 after a review of 8 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 Harry J. Bosworth Co. devices

Submission Details

510(k) Number K800548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1980
Decision Date March 18, 1980
Days to Decision 8 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 127d · This submission: 8d
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 116
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K800548.
ALGINATE IMPRESSION MATERIAL
K802362 · Dentsply Intl. · Oct 1980
ASH BLUEPRINT ALGINATE IMPRESSION MATER.
K801587 · Dentsply Intl. · Jul 1980
VINYL POLYSILOXANE IMPRESSION MATERIAL
K800485 · 3M Company · Mar 1980
SILAGUM
K792363 · Parkell, Inc. · Jan 1980
REPROSIL
K781151 · Dentsply Intl. · Aug 1978
PERMAGUM ADHESIVE
K771853 · Espe GmbH (Us) · Oct 1977