Cleared Traditional

K894247 - PERIODONTAL IRRIGATING SOLUTION-D

K894247 is an FDA 510(k) clearance for PERIODONTAL IRRIGATING SOLUTION-D, 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 107-day FDA review.

K894247 · Dentsply Intl. · Dental device
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Oct 1989
Decision
107d
Days
Class 2
Risk

K894247 is an FDA 510(k) clearance for the PERIODONTAL IRRIGATING SOLUTION-D. 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 6, 1989 after a review of 107 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 - K894247

510(k) Number K894247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1989
Decision Date October 06, 1989
Days to Decision 107 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
20d faster than avg
Panel avg: 127d · This submission: 107d
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 K894247.
DIAMOND COATED DENTAL INSERTS
K923639 · Dentsply Intl. · Oct 1992
PERIODONTAL DEBRIDING SOLUTION E
K903163 · Dentsply Intl. · Oct 1990
SONIC SCALER
K902413 · Dentsply Intl. · Aug 1990
ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30
K864996 · Dentsply Intl. · Feb 1987
ULTRASONIC TOOTH SCALER MODEL DSCIOP
K852540 · Parkell, Inc. · Jul 1985
CAVI-MED
K842581 · Cooper Lasersonics, Inc. · Aug 1984