Cleared Traditional

CBM, CORE BUILD-UP MATERIAL (K823732) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K823732 · Scientific Pharmaceuticals, Inc. · Dental device
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Dec 1982
Decision
18d
Days
Class 2
Risk

K823732 is an FDA 510(k) clearance for the CBM, CORE BUILD-UP MATERIAL. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Scientific Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K823732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1982
Decision Date December 28, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 127d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 13
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K823732.
J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT
K850073 · Johnson & Johnson Professionals, Inc. · Feb 1985
OPAQUE COATING & SURFACE STAIN
K840751 · Dentsply Intl. · May 1984
CONCISE 2 SMALL PARTICLE LIGHT CURVED
K832834 · 3M Company · Sep 1983
CONCLUDE COMPOSITE LUTING CEMENT
K822714 · 3M Company · Sep 1982
MYERSON/KENSON GP POLYMER
K813328 · Howmedica Corp. · Feb 1982