Cleared Traditional

K923639 - DIAMOND COATED DENTAL INSERTS

K923639 is an FDA 510(k) clearance for DIAMOND COATED DENTAL INSERTS, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K923639 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
97d
Days
Class 2
Risk

K923639 is an FDA 510(k) clearance for the DIAMOND COATED DENTAL INSERTS. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on October 26, 1992 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K923639

510(k) Number K923639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1992
Decision Date October 26, 1992
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 127d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 136
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K923639.
JET UNIT (CJ HANDPIECE)
K941392 · Dentsply Intl. · May 1994
INTRA-ORAL IRRIGATOR
K933547 · Parkell, Inc. · Oct 1993
THE MODEL 3003 SCALER
K930698 · Dentsply Intl. · Jul 1993
PERIODONTAL DEBRIDING SOLUTION E
K903163 · Dentsply Intl. · Oct 1990
SONIC SCALER
K902413 · Dentsply Intl. · Aug 1990
PERIODONTAL IRRIGATING SOLUTION-D
K894247 · Dentsply Intl. · Oct 1989