Cleared Traditional

K854690 - DIAMONDS BURS-COMPOSIT FINISHING

K854690 is an FDA 510(k) clearance for DIAMONDS BURS-COMPOSIT FINISHING, manufactured by Almore Intl., Inc.. The device is a Class 1 Dental device with product code EJL cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K854690 · Almore Intl., Inc. · Dental device
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Mar 1986
Decision
124d
Days
Class 1
Risk

K854690 is an FDA 510(k) clearance for the DIAMONDS BURS-COMPOSIT FINISHING. Classified as Bur, Dental (product code EJL), Class I - General Controls.

Submitted by Almore Intl., Inc. (Portland, US). The FDA issued a Cleared decision on March 25, 1986 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3240 - 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.

FDA 510(k) Submission Details - K854690

510(k) Number K854690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1985
Decision Date March 25, 1986
Days to Decision 124 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
4d faster than avg
Panel avg: 128d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

EJL Device Classification - Class 1, General Controls

Product Code EJL Bur, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3240
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 - EJL Bur, Dental

All 26
Devices cleared under the same product code (EJL) and FDA review panel - the closest regulatory comparables to K854690.
DENTAL BURS
K882183 · Tri-Stage, Inc. · Jun 1988
STERILIZED DENTAL BIT PACKAGING
K873698 · Florida Diamond Instruments Corp. · Dec 1987
CB BUR
K863097 · Beavers Dental, Div. Sybron Canada, Ltd. · Aug 1986
DIAMOND BURS-HANDPIECE
K854691 · Almore Intl., Inc. · Mar 1986
BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL
K842720 · Penn-Med Technology, Inc. · May 1985
LEBLOND DIAMOND DENTAL BUR
K833598 · A & M Instruments, Inc. · Dec 1983
K854690 · DIAMONDS BURS-COMPOSIT FINISHING
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