Cleared Traditional

CURAY ANTERIOR/POSTERIOR RESTORATIVE (K823510) - FDA 510(k) Clearance

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

K823510 · Scientific Pharmaceuticals, Inc. · Dental device
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Dec 1982
Decision
29d
Days
Class 2
Risk

K823510 is an FDA 510(k) clearance for the CURAY ANTERIOR/POSTERIOR RESTORATIVE. Classified as Material, Tooth Shade, Resin (product code EBF), 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 29 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 Scientific Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K823510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1982
Decision Date December 28, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 127d · This submission: 29d
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 195
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K823510.
CERTAIN *DENTAL RESTORATIVE
K831559 · Johnson & Johnson Professionals, Inc. · Jun 1983
MICRODAPT DENTAL RESTORATIVE
K830380 · Johnson & Johnson Professionals, Inc. · Mar 1983
PRISMA-FINE
K830442 · Dentsply Intl. · Mar 1983
GAMMA LIGHT CURING DENTAL RESTORATIVE
K823185 · Johnson & Johnson Professionals, Inc. · Nov 1982
AURAFILL* DENTAL RESTORATIVE
K822450 · Johnson & Johnson Professionals, Inc. · Sep 1982
CAULK OPAQUER
K813357 · Dentsply Intl. · Jan 1982