Cleared Traditional

K901873 - DEGUFILL POLISHING GEL

K901873 is the FDA 510(k) clearance for DEGUFILL POLISHING GEL by Degussa AG. It is a Class 1 Dental device (product code EJR) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K901873 · Degussa AG · Dental device
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Aug 1990
Decision
111d
Days
Class 1
Risk

K901873 is an FDA 510(k) clearance for the DEGUFILL (R) POLISHING GEL. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Degussa AG (West Germany, DE). The FDA issued a Cleared decision on August 13, 1990 after a review of 111 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 Degussa AG devices

Submission Details

510(k) Number K901873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1990
Decision Date August 13, 1990
Days to Decision 111 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
16d faster than avg
Panel avg: 127d · This submission: 111d
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 26
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K901873.
PULPDENT DIAMOND POLISH
K911284 · Pulpdent Corp. · May 1991
PROPHY PASTE
K901580 · Dentsply Intl. · Sep 1990
ULTRA II PORCELAIN POLISHING PASTE
K896071 · Shofu Dental Corp. · Aug 1990
PULPDENT OIL FREE SURFACE PREPARATION PASTE
K901052 · Pulpdent Corp. · Apr 1990
KEN'S PROPHY GEL - REGULAR
K896661 · Pulpdent Corp. · Feb 1990
ENAMEL MICROABRASION COMPOUND
K891536 · Premier Dental Products Co. · Jun 1989