Cleared Traditional

K811427 - SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM

K811427 is the FDA 510(k) clearance for SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K811427 · Harry J. Bosworth Co. · Dental device
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Aug 1981
Decision
90d
Days
Class 2
Risk

K811427 is an FDA 510(k) clearance for the SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1981 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K811427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1981
Decision Date August 20, 1981
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 474
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K811427.
CAULK OPAQUER
K813357 · Dentsply Intl. · Jan 1982
ADAPTIC* C.F.S.
K812449 · Johnson & Johnson Professionals, Inc. · Sep 1981
VISIO-FIL
K812169 · Espe GmbH (Us) · Sep 1981
ENHANCE DENTAL RESTORATIVE
K811443 · Johnson & Johnson Professionals, Inc. · Jun 1981
SILUX RESTORATIVE MATERIAL & ENAMEL BOND
K810595 · 3M Company · Mar 1981
ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE
K802975 · Dentsply Intl. · Jan 1981