Cleared Traditional

K930583 - MEGABOND SYSTEM

K930583 is an FDA 510(k) clearance for MEGABOND SYSTEM, manufactured by Scientific Pharmaceuticals, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 383-day FDA review.

K930583 · Scientific Pharmaceuticals, Inc. · Dental device
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Feb 1994
Decision
383d
Days
Class 2
Risk

K930583 is an FDA 510(k) clearance for the MEGABOND SYSTEM. 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

FDA 510(k) Submission Details - K930583

510(k) Number K930583 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.

EBF Device Classification - Class 2, Special Controls

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 798
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K930583.
CONQUEST SENIOR
K941376 · Jeneric/Pentron, Inc. · May 1994
PROCOM
K941378 · Jeneric/Pentron, Inc. · May 1994
DENTACOLOR VITA (VS) SHADE SYSTEM
K940800 · Heraeus Kulzer, Inc. · Apr 1994
MAGNACORE
K930584 · Scientific Pharmaceuticals, Inc. · Feb 1994
TI-CORE-NATURAL
K922251 · Essential Dental Systems, Inc. · Jan 1994
TI-CORE NEW & IMPROVED
K922252 · Essential Dental Systems, Inc. · Jan 1994