Cleared Traditional

K923675 - DENSPRO MEDIUM MINT PROPHY PASTE

K923675 is an FDA 510(k) clearance for DENSPRO MEDIUM MINT PROPHY PASTE, manufactured by Teledyne Getz. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K923675 · Teledyne Getz · Dental device
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Nov 1992
Decision
106d
Days
Class 1
Risk

K923675 is an FDA 510(k) clearance for the DENSPRO MEDIUM MINT PROPHY PASTE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Teledyne Getz (Elk Grove Village, US). The FDA issued a Cleared decision on November 5, 1992 after a review of 106 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 Teledyne Getz devices

FDA 510(k) Submission Details - K923675

510(k) Number K923675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1992
Decision Date November 05, 1992
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
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 30
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K923675.
MI PASTE
K042200 · GC America, Inc. · Oct 2004
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
PULPDENT DIAMOND POLISH
K911284 · Pulpdent Corp. · May 1991
PROPHY PASTE
K901580 · Dentsply Intl. · Sep 1990