Cleared Traditional

K923462 - DELIGHT

K923462 is an FDA 510(k) clearance for DELIGHT, manufactured by Planmeca USA, Inc.. The device is a Class 1 Dental device with product code EAZ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K923462 · Planmeca USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
160d
Days
Class 1
Risk

K923462 is an FDA 510(k) clearance for the DELIGHT. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Planmeca USA, Inc. (Finland, FI). The FDA issued a Cleared decision on December 21, 1992 after a review of 160 days - an extended review cycle.

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. 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 Planmeca USA, Inc. devices

FDA 510(k) Submission Details - K923462

510(k) Number K923462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1992
Decision Date December 21, 1992
Days to Decision 160 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 127d · This submission: 160d
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 K923462.
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