Cleared Traditional

K874557 - BISCO PORCELAIN REPAIR KIT

K874557 is the FDA 510(k) clearance for BISCO PORCELAIN REPAIR KIT by Bisco, Inc.. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K874557 · Bisco, Inc. · Dental device
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Jan 1988
Decision
85d
Days
Class 2
Risk

K874557 is an FDA 510(k) clearance for the BISCO PORCELAIN REPAIR KIT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Bisco, Inc. (Downers Grove, US). The FDA issued a Cleared decision on January 28, 1988 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 Bisco, Inc. devices

Submission Details

510(k) Number K874557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1987
Decision Date January 28, 1988
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 62
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K874557.
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE
K896341 · Dentsply Intl. · Apr 1990
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
K874944 · Dentsply Intl. · Feb 1988
BISCO PIT AND FISSURE SEALANT
K874556 · Bisco, Inc. · Jan 1988
MODIFIED VISIO-SEAL
K873069 · Espe GmbH (Us) · Sep 1987
PRISMA METAL OPAQUERS
K862660 · Dentsply Intl. · Jul 1986
SEALITE
K862284 · Sybron Corp. · Jun 1986