Cleared Traditional

K823413 - MOUTH CARE KIT W/TOOTHBRUSH

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

FDA 510(k) Submission Details - K823413

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 127d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -