Cleared Traditional

UNIREST COMPOSITE RESTORATIVE, SELF CURED (K884350) - FDA 510(k) Clearance

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

K884350 · Scientific Pharmaceuticals, Inc. · Dental device
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Jan 1989
Decision
81d
Days
Class 2
Risk

K884350 is an FDA 510(k) clearance for the UNIREST COMPOSITE RESTORATIVE, SELF CURED. 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 January 3, 1989 after a review of 81 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 K884350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1988
Decision Date January 03, 1989
Days to Decision 81 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 127d · This submission: 81d
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 K884350.
3M BRAND RESTORATIVE Z100
K920425 · 3M Company · Mar 1992
STOMADENT TM
K905476 · Dentsply Intl. · Feb 1991
DENTAL CORE MATERIAL
K896564 · Dentsply Intl. · Feb 1990
SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL
K872444 · 3M Company · Sep 1987
DENTIN ADHESIVE
K872907 · Dentsply Intl. · Aug 1987
SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER
K872279 · 3M Company · Jul 1987