Cleared Traditional

ALOE THERAPY ORAL RINSE (K983182) - FDA 510(k) Clearance

K983182 · Carrington Laboratories, Inc. · General & Plastic Surgery device
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Dec 1998
Decision
90d
Days
-
Risk

K983182 is an FDA 510(k) clearance for the ALOE THERAPY ORAL RINSE. Classified as Oral Wound Dressing (product code OLR).

Submitted by Carrington Laboratories, Inc. (Crofton, US). The FDA issued a Cleared decision on December 10, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K983182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1998
Decision Date December 10, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.