Cleared Traditional

K930337 - PROFAST(R)-DENTURE CLEANSER (FDA 510(k) Clearance)

Class I Dental device.

K930337 · Fittydent-Altwirth & Schmitt GmbH · Dental device
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Sep 1993
Decision
228d
Days
Class 1
Risk

K930337 is an FDA 510(k) clearance for the PROFAST(R)-DENTURE CLEANSER. Classified as Cleanser, Denture, Over The Counter (product code EFT), Class I - General Controls.

Submitted by Fittydent-Altwirth & Schmitt GmbH (Chicago, US). The FDA issued a Cleared decision on September 7, 1993 after a review of 228 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3520 - 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 Fittydent-Altwirth & Schmitt GmbH devices

Submission Details

510(k) Number K930337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1993
Decision Date September 07, 1993
Days to Decision 228 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
101d slower than avg
Panel avg: 127d · This submission: 228d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFT Cleanser, Denture, Over The Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3520
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.