Cleared Traditional

EZ-ON TUBING CONDITIONER (LUBRICANT) (K854700) - FDA 510(k) Clearance

K854700 · Almore Intl., Inc. · Dental device
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Mar 1986
Decision
111d
Days
-
Risk

K854700 is an FDA 510(k) clearance for the EZ-ON TUBING CONDITIONER (LUBRICANT).

Submitted by Almore Intl., Inc. (Portland, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 111 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 Almore Intl., Inc. devices

Submission Details

510(k) Number K854700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1985
Decision Date March 12, 1986
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 127d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -