Cleared Traditional

K854697 - TUBING HANDPIECE REPLACEMENT

K854697 is an FDA 510(k) clearance for TUBING HANDPIECE REPLACEMENT, manufactured by Almore Intl., Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K854697 · Almore Intl., Inc. · Dental device
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Mar 1986
Decision
105d
Days
Class 1
Risk

K854697 is an FDA 510(k) clearance for the TUBING HANDPIECE REPLACEMENT. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Almore Intl., Inc. (Portland, US). The FDA issued a Cleared decision on March 6, 1986 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. 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 - K854697

510(k) Number K854697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1985
Decision Date March 06, 1986
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 174
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K854697.
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