Cleared Traditional

K811427 - SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM

K811427 is an FDA 510(k) clearance for SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM, manufactured by Harry J. Bosworth Co.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K811427

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
Combination Product No
PCCP Authorized No
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.

EBF Device Classification - Class 2, Special Controls

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 758
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K811427.
ESTILUX POSTERIOR
K812889 · Kulzer, Inc. · Nov 1981
ADAPTIC* C.F.S.
K812449 · Johnson & Johnson Professionals, Inc. · Sep 1981
VISIO-FIL
K812169 · Espe GmbH (Us) · Sep 1981
DURAFILL MICROFILL RESTORATIVE MATERIAL
K811669 · Kulzer, Inc. · Jul 1981
ENHANCE DENTAL RESTORATIVE
K811443 · Johnson & Johnson Professionals, Inc. · Jun 1981
SILUX RESTORATIVE MATERIAL & ENAMEL BOND
K810595 · 3M Company · Mar 1981