Cleared Traditional

K930335 - PROFAST - DENTURE ADHESIVE FOR LOWER JAWS (FDA 510(k) Clearance)

Class I Dental device.

K930335 · Fittydent-Altwirth & Schmitt GmbH · Dental device
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Feb 1994
Decision
375d
Days
Class 1
Risk

K930335 is an FDA 510(k) clearance for the PROFAST - DENTURE ADHESIVE FOR LOWER JAWS. Classified as Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt (product code KOO), Class I - General Controls.

Submitted by Fittydent-Altwirth & Schmitt GmbH (Chicago, US). The FDA issued a Cleared decision on February 1, 1994 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3490 - 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. Elevated predicate reliance profile. 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 K930335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1993
Decision Date February 01, 1994
Days to Decision 375 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
248d slower than avg
Panel avg: 127d · This submission: 375d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOO Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3490
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.