Cleared Traditional

K854700 - EZ-ON TUBING CONDITIONER (LUBRICANT)

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

FDA 510(k) Submission Details - K854700

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 127d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -