Cleared Traditional

K992380 - ENDO-EZE MOTOR AND HANDPIECE

K992380 is the FDA 510(k) clearance for ENDO-EZE MOTOR AND HANDPIECE by Ultradent Products, Inc.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K992380 · Ultradent Products, Inc. · Dental device
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Oct 1999
Decision
89d
Days
Class 1
Risk

K992380 is an FDA 510(k) clearance for the ENDO-EZE MOTOR AND HANDPIECE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 13, 1999 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Ultradent Products, Inc. devices

Submission Details

510(k) Number K992380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1999
Decision Date October 13, 1999
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EFB Handpiece, Air-powered, Dental

All 77
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K992380.
RAPIDD HIGHSPEED DENTAL HANDPIECE
K003518 · Dentsply Intl. · Jan 2001
SYNEA - LS LOW-SPEED HANDPIECE
K993526 · A-Dec, Inc. · Jan 2000
LC COMPOSITE
K991492 · Harry J. Bosworth Co. · Dec 1999
SYNEA-HS HIGH SPEED-HANDPIECE
K992011 · A-Dec, Inc. · Sep 1999
MODEL MS-2 HANDPIECE
K982050 · Parkell, Inc. · Sep 1998
W&H 900 INCOLIGHT LT HANDPIECE
K944718 · A-Dec, Inc. · Oct 1995