Cleared Traditional

VISION PROPHY PASTE WITHOUT FLUORIDE (K933893) - FDA 510(k) Clearance

Class I Dental device.

K933893 · Block Drug Company, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
98d
Days
Class 1
Risk

K933893 is an FDA 510(k) clearance for the VISION PROPHY PASTE WITHOUT FLUORIDE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Block Drug Company, Inc. (Jersey City, US). The FDA issued a Cleared decision on November 16, 1993 after a review of 98 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 Block Drug Company, Inc. devices

Submission Details

510(k) Number K933893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1993
Decision Date November 16, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 127d · This submission: 98d
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 K933893.
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
K000169 · Dentsply Intl. · Mar 2000
NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
K983966 · Dentsply Intl. · Jan 1999
SATIN PROPHYLAXIS PASTE
K912945 · Dentsply Intl. · Sep 1991
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