Cleared Traditional

K854828 - SCI-PRO, PROPHYLAXIS PASTE

K854828 is an FDA 510(k) clearance for SCI-PRO, manufactured by Scientific Pharmaceuticals, Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 113-day FDA review.

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

FDA 510(k) Submission Details - K854828

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

EJR Device Classification - Class 1, General Controls

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 38
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K854828.
ABRASIVE DISC - POLISHING WHEEL
K872251 · Dentsply Intl. · Jul 1987
JOHNSON & JOHNSON STAINING REMOVING COMPOUND
K864226 · Johnson & Johnson Professionals, Inc. · May 1987
RENAMELIZE POLISHING PASTE
K862912 · Cosmedent, Inc. · Aug 1986
DENSCO PROPHY PASTE
K854829 · Scientific Pharmaceuticals, Inc. · Mar 1986
GLOSSY POLISHING PASTE
K852814 · Scientific Pharmaceuticals, Inc. · Jul 1985
TEMREX DENTAL POLISHING PASTE
K852157 · Scientific Pharmaceuticals, Inc. · Jul 1985