Cleared Traditional

K925629 - ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT

K925629 is an FDA 510(k) clearance for ACCESSORY TO IMPROVED DENTAL OPERATING ..., manufactured by Den-Tal-Ez Mfg Co., Inc.. The device is a Class 1 Dental device with product code EAZ cleared through the Traditional 510(k) pathway after a 382-day FDA review.

K925629 · Den-Tal-Ez Mfg Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
382d
Days
Class 1
Risk

K925629 is an FDA 510(k) clearance for the ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Den-Tal-Ez Mfg Co., Inc. (Lancaster, US). The FDA issued a Cleared decision on November 23, 1993 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - 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. Elevated predicate reliance profile. 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 Den-Tal-Ez Mfg Co., Inc. devices

FDA 510(k) Submission Details - K925629

510(k) Number K925629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1992
Decision Date November 23, 1993
Days to Decision 382 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 127d · This submission: 382d
Pathway characteristics
Predicate-based equivalence.

EAZ Device Classification - Class 1, General Controls

Product Code EAZ Light, Operating, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
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 - EAZ Light, Operating, Dental

All 7
Devices cleared under the same product code (EAZ) and FDA review panel - the closest regulatory comparables to K925629.
MICROLUX/BLU
K072309 · Addent, Inc. · Nov 2007
MICROLUX DL
K041614 · Addent, Inc. · Apr 2005
DENTAL LIGHT
K926081 · Mdt Corp., Inc. · Jan 1994
A-DEC DENTAL LIGHT
K893044 · A-Dec, Inc. · Jul 1989
F-11 REFLECTOR / F-II STANDARD REFLECTOR
K863019 · Sds Dental, Inc. · Sep 1986
OPTI-BEAM IV
K832919 · Dentsply Intl. · Mar 1984