Cleared Traditional

MATERIAL TOOTHSADE RESIN (K834247) - FDA 510(k) Clearance

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

K834247 · Scientific Pharmaceuticals, Inc. · Dental device
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Feb 1984
Decision
65d
Days
Class 2
Risk

K834247 is an FDA 510(k) clearance for the MATERIAL TOOTHSADE RESIN. 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 February 10, 1984 after a review of 65 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 K834247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1983
Decision Date February 10, 1984
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 127d · This submission: 65d
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 K834247.
SCOTCHBOND LIGHT CURED DENTAL ADHES
K841550 · 3M Company · Jun 1984
JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II)
K841518 · Johnson & Johnson Professionals, Inc. · May 1984
LIGHT CURED RESIN BONDED CERAMIC
K833797 · 3M Company · Apr 1984
LUXENE VINYL-JECT 3600-80
K834046 · Howmedica Corp. · Feb 1984
LIGHT CURING BONDING AGENT
K832061 · Johnson & Johnson Professionals, Inc. · Aug 1983
ADAPTIC*FAST SET DENTAL RESTORATIVE
K832062 · Johnson & Johnson Professionals, Inc. · Aug 1983