Cleared Traditional

K873698 - STERILIZED DENTAL BIT PACKAGING

K873698 is an FDA 510(k) clearance for STERILIZED DENTAL BIT PACKAGING, manufactured by Florida Diamond Instruments Corp.. The device is a Class 1 Dental device with product code EJL cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K873698 · Florida Diamond Instruments Corp. · Dental device
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Dec 1987
Decision
80d
Days
Class 1
Risk

K873698 is an FDA 510(k) clearance for the STERILIZED DENTAL BIT PACKAGING. Classified as Bur, Dental (product code EJL), Class I - General Controls.

Submitted by Florida Diamond Instruments Corp. (Fort Myers, US). The FDA issued a Cleared decision on December 3, 1987 after a review of 80 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Florida Diamond Instruments Corp. devices

FDA 510(k) Submission Details - K873698

510(k) Number K873698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1987
Decision Date December 03, 1987
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 128d · This submission: 80d
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 8
Devices cleared under the same product code (EJL) and FDA review panel - the closest regulatory comparables to K873698.
SMARTBURS
K080687 · S.S. White Burs, Inc. · Jun 2008
CERADRILL
K071352 · Gebr. Brasseler GmbH & Co. KG · Jun 2007
BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
K061383 · B.T.I. Biotechnology Institute, Sl. · Aug 2006
DIAMONDS BURS-COMPOSIT FINISHING
K854690 · Almore Intl., Inc. · Mar 1986
DIAMOND BURS-HANDPIECE
K854691 · Almore Intl., Inc. · Mar 1986
DENTAL INSTRUMENTS
K823314 · Miltex, Inc. · Nov 1982