Cleared Traditional

K915668 - BISCO CAVITY CLEANSER

K915668 is the FDA 510(k) clearance for BISCO CAVITY CLEANSER by Bisco, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K915668 · Bisco, Inc. · Dental device
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Apr 1992
Decision
125d
Days
Class 2
Risk

K915668 is an FDA 510(k) clearance for the BISCO CAVITY CLEANSER. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on April 21, 1992 after a review of 125 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 Bisco, Inc. devices

Submission Details

510(k) Number K915668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1991
Decision Date April 21, 1992
Days to Decision 125 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 127d · This submission: 125d
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 516
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K915668.
PUPLDENT ETCH N PREP
K920485 · Pulpdent Corp. · Apr 1992
14% HYDROFLUORIC ACID ETCHING GEL
K920482 · Pulpdent Corp. · Apr 1992
2.5% NITRIC ACID ETCHING GEL
K920484 · Pulpdent Corp. · Apr 1992
3M BRAND RESTORATIVE Z100
K920425 · 3M Company · Mar 1992
TOOTH BONDING AGENT
K920365 · Voco GmbH · Mar 1992
DENTACOLOR(R) CRE-ACTIVE
K914456 · Heraeus Kulzer, Inc. · Mar 1992