Cleared Traditional

K241354 - Sealer Solvent (FDA 510(k) Clearance)

K241354 · Inter-Med, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Aug 2024
Decision
106d
Days
-
Risk

K241354 is an FDA 510(k) clearance for the Sealer Solvent. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on August 27, 2024 after a review of 106 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 Inter-Med, Inc. devices

Submission Details

510(k) Number K241354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2024
Decision Date August 27, 2024
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -