Cleared Traditional

K861148 - BISCO'S PORCELAIN VENEER SYSTEM

K861148 is the FDA 510(k) clearance for BISCO'S PORCELAIN VENEER SYSTEM by Bisco, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K861148 · Bisco, Inc. · Dental device
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Apr 1986
Decision
35d
Days
Class 2
Risk

K861148 is an FDA 510(k) clearance for the BISCO'S PORCELAIN VENEER SYSTEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Bisco, Inc. (Lombard, US). The FDA issued a Cleared decision on April 30, 1986 after a review of 35 days - a notably fast clearance cycle.

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: 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 K861148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1986
Decision Date April 30, 1986
Days to Decision 35 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
92d faster than avg
Panel avg: 127d · This submission: 35d
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 K861148.
RESTOR (COMET)*DENTAL RESTORATIVE
K861833 · Johnson & Johnson Professionals, Inc. · Jul 1986
SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE
K861899 · 3M Company · Jun 1986
P-50 LIGHT CURED RESIN BONDED CERAMIC
K861740 · 3M Company · May 1986
NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID
K860626 · Scientific Pharmaceuticals, Inc. · Apr 1986
SCI-PHARM UNIFIL ANTERIOR/POSTERIOR LIQUID/PASTE
K860627 · Scientific Pharmaceuticals, Inc. · Mar 1986
DENTAL CEMENT
K853431 · Dentsply Intl. · Oct 1985