Cleared Traditional

ORAL SPONGE (K823136) - FDA 510(k) Clearance

K823136 · Amisplint · Dental device
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Mar 1983
Decision
157d
Days
-
Risk

K823136 is an FDA 510(k) clearance for the ORAL SPONGE.

Submitted by Amisplint (Mchenry, US). The FDA issued a Cleared decision on March 31, 1983 after a review of 157 days - an extended review cycle.

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.

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Submission Details

510(k) Number K823136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1982
Decision Date March 31, 1983
Days to Decision 157 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 127d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -