Cleared Traditional

SCI-PHARM POLIFIL ANTERIOR RESTORATIVE (K791602) - FDA 510(k) Clearance

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

K791602 · Scientific Pharmaceuticals, Inc. · Dental device
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Nov 1979
Decision
105d
Days
Class 2
Risk

K791602 is an FDA 510(k) clearance for the SCI-PHARM POLIFIL ANTERIOR RESTORATIVE. 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 November 27, 1979 after a review of 105 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 K791602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1979
Decision Date November 27, 1979
Days to Decision 105 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 127d · This submission: 105d
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 K791602.
ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE
K802125 · Dentsply Intl. · Sep 1980
PRISMA-FIL
K801732 · Dentsply Intl. · Aug 1980
PRISMA-FILL
K801092 · Dentsply Intl. · May 1980
MIRADAPT* DENTAL RESTORATIVE
K791318 · Johnson & Johnson Professionals, Inc. · Sep 1979
FOTOFILL DENTAL RESTORATIVE
K772279 · Johnson & Johnson Professionals, Inc. · Jan 1978