Cleared Traditional

K823413 - MOUTH CARE KIT W/TOOTHBRUSH (FDA 510(k) Clearance)

K823413 · Sage Products, Inc. · Dental device
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Mar 1983
Decision
134d
Days
-
Risk

K823413 is an FDA 510(k) clearance for the MOUTH CARE KIT W/TOOTHBRUSH.

Submitted by Sage Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 29, 1983 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. 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 Sage Products, Inc. devices

Submission Details

510(k) Number K823413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1982
Decision Date March 29, 1983
Days to Decision 134 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 127d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -