Cleared Traditional

K935390 - SIROLUX FANTASTIC

K935390 is an FDA 510(k) clearance for SIROLUX FANTASTIC, manufactured by Pelton & Crane Co.. The device is a Class 1 Dental device with product code EAZ cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K935390 · Pelton & Crane Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
32d
Days
Class 1
Risk

K935390 is an FDA 510(k) clearance for the SIROLUX FANTASTIC. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Pelton & Crane Co. (Charlotte, US). The FDA issued a Cleared decision on December 10, 1993 after a review of 32 days - a notably fast clearance 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: 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 Pelton & Crane Co. devices

FDA 510(k) Submission Details - K935390

510(k) Number K935390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1993
Decision Date December 10, 1993
Days to Decision 32 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
95d faster than avg
Panel avg: 127d · This submission: 32d
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 K935390.
MICROLUX/BLU
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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