Cleared Traditional

K930584 - MAGNACORE

K930584 is the FDA 510(k) clearance for MAGNACORE by Scientific Pharmaceuticals, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 383-day FDA review.

K930584 · Scientific Pharmaceuticals, Inc. · Dental device
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Feb 1994
Decision
383d
Days
Class 2
Risk

K930584 is an FDA 510(k) clearance for the MAGNACORE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Skokie, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Scientific Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K930584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1993
Decision Date February 22, 1994
Days to Decision 383 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
256d slower than avg
Panel avg: 127d · This submission: 383d
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 K930584.
PROCOM
K941378 · Jeneric/Pentron, Inc. · May 1994
DENTACOLOR VITA (VS) SHADE SYSTEM
K940800 · Heraeus Kulzer, Inc. · Apr 1994
MEGABOND SYSTEM
K930583 · Scientific Pharmaceuticals, Inc. · Feb 1994
CHARISMA SUPERLIGHT
K935736 · Heraeus Kulzer, Inc. · Jan 1994
BISCO UNIVERSAL HYBRID COMPOSITE
K934247 · Bisco, Inc. · Nov 1993
STO2P
K934611 · Ivoclar North America, Inc. · Nov 1993