Cleared Traditional

SANI-DENT DENTURE CLEANER (K781779) - FDA 510(k) Clearance

Class I Dental device.

K781779 · Sandi-Dent · Dental device
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Nov 1978
Decision
156d
Days
Class 1
Risk

K781779 is an FDA 510(k) clearance for the SANI-DENT DENTURE CLEANER. Classified as Cleaner, Denture, Mechanical (product code JER), Class I - General Controls.

Submitted by Sandi-Dent (Mchenry, US). The FDA issued a Cleared decision on November 8, 1978 after a review of 156 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3530 - 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 Sandi-Dent devices

Submission Details

510(k) Number K781779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1978
Decision Date November 08, 1978
Days to Decision 156 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 127d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JER Cleaner, Denture, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3530
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.