Cleared Traditional

K790789 - COMPOSITE RESTORATIVE

K790789 is the FDA 510(k) clearance for COMPOSITE RESTORATIVE by Scientific Pharmaceuticals, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K790789 · Scientific Pharmaceuticals, Inc. · Dental device
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Jul 1979
Decision
73d
Days
Class 2
Risk

K790789 is an FDA 510(k) clearance for the COMPOSITE RESTORATIVE, PASTE/PASTE TYPE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Walker, US). The FDA issued a Cleared decision on July 6, 1979 after a review of 73 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 K790789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1979
Decision Date July 06, 1979
Days to Decision 73 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
54d faster than avg
Panel avg: 127d · This submission: 73d
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 577
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K790789.
SCI-PHARM POLIFIL ANTERIOR RESTORATIVE
K791602 · Scientific Pharmaceuticals, Inc. · Nov 1979
VISIO-DISPERS
K790823 · Espe GmbH (Us) · Oct 1979
MIRADAPT* DENTAL RESTORATIVE
K791318 · Johnson & Johnson Professionals, Inc. · Sep 1979
ANTERIOR/POSTERIOR RESTORATIVE LIQUID
K790822 · Scientific Pharmaceuticals, Inc. · Jul 1979
PAINT-ON RESTORATIVE, LIGHT CURED
K790963 · Scientific Pharmaceuticals, Inc. · Jul 1979
DENTAL COMPOSITE RESTORATIVE MATERIAL
K790594 · Wallace A. Erickson & Co. · Jun 1979