Cleared Traditional

SCI-PRO, PROPHYLAXIS PASTE (K854828) - FDA 510(k) Clearance

Class I Dental device.

K854828 · Scientific Pharmaceuticals, Inc. · Dental device
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Mar 1986
Decision
113d
Days
Class 1
Risk

K854828 is an FDA 510(k) clearance for the SCI-PRO, PROPHYLAXIS PASTE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Duarte, US). The FDA issued a Cleared decision on March 26, 1986 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - 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 K854828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1985
Decision Date March 26, 1986
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EJR Agent, Polishing, Abrasive, Oral Cavity

All 7
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K854828.
PROPHY PASTE
K901580 · Dentsply Intl. · Sep 1990
ABRASIVE DISC - POLISHING WHEEL
K872251 · Dentsply Intl. · Jul 1987
JOHNSON & JOHNSON STAINING REMOVING COMPOUND
K864226 · Johnson & Johnson Professionals, Inc. · May 1987
MIRADAPT* POLISHING INSTRUMENTS
K791319 · Johnson & Johnson Professionals, Inc. · Sep 1979