Cleared Traditional

K863676 - GENTEEL

K863676 is an FDA 510(k) clearance for GENTEEL, manufactured by Luben Dental Co., Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K863676 · Luben Dental Co., Inc. · Dental device
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Oct 1986
Decision
13d
Days
Class 2
Risk

K863676 is an FDA 510(k) clearance for the GENTEEL. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Luben Dental Co., Inc. (New York, US). The FDA issued a Cleared decision on October 2, 1986 after a review of 13 days - a notably fast clearance cycle.

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: 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 Luben Dental Co., Inc. devices

FDA 510(k) Submission Details - K863676

510(k) Number K863676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1986
Decision Date October 02, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 128d · This submission: 13d
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 142
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K863676.
SONIC SCALER
K902413 · Dentsply Intl. · Aug 1990
PERIODONTAL IRRIGATING SOLUTION-D
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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
DENTAL ULTRASONIC SCALER/ENDOSONIC
K840141 · CooperVision, Inc. · Mar 1984