Cleared Traditional

TWIN-CORE (K863031) - FDA 510(k) Clearance

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

K863031 · Scientific Pharmaceuticals, Inc. · Dental device
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Sep 1986
Decision
42d
Days
Class 2
Risk

K863031 is an FDA 510(k) clearance for the TWIN-CORE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Duarte, US). The FDA issued a Cleared decision on September 22, 1986 after a review of 42 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 K863031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1986
Decision Date September 22, 1986
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 127d · This submission: 42d
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 K863031.
ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM
K871295 · Johnson & Johnson Professionals, Inc. · May 1987
IMPROVED COMSPAN
K863552 · Dentsply Intl. · Oct 1986
CAULK'S POLISHING PASTE
K863174 · Dentsply Intl. · Oct 1986
DENTAL COMPOSITE RESTORATIVE
K863092 · Dentsply Intl. · Sep 1986
RESTOR (COMET)*DENTAL RESTORATIVE
K861833 · Johnson & Johnson Professionals, Inc. · Jul 1986
SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE
K861899 · 3M Company · Jun 1986