Cleared Traditional

K893458 - FIBEROPTIC HEADLIGHT SYSTEM

K893458 is an FDA 510(k) clearance for FIBEROPTIC HEADLIGHT SYSTEM, manufactured by Cuda Products Co.. The device is a Class 1 Dental device with product code EBA cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K893458 · Cuda Products Co. · Dental device
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Jun 1989
Decision
51d
Days
Class 1
Risk

K893458 is an FDA 510(k) clearance for the FIBEROPTIC HEADLIGHT SYSTEM. Classified as Light, Surgical Headlight (product code EBA), Class I - General Controls.

Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 51 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.

FDA 510(k) Submission Details - K893458

510(k) Number K893458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date June 22, 1989
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 128d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

EBA Device Classification - Class 1, General Controls

Product Code EBA Light, Surgical Headlight
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 - EBA Light, Surgical Headlight

All 9
Devices cleared under the same product code (EBA) and FDA review panel - the closest regulatory comparables to K893458.
PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
K070287 · Photonic Optische Gerate GmbH & Cokg · Feb 2007
SYLVAN DENTAL HEADLIGHT SYSTEM
K923949 · Sylvan Medical Fiberoptics · Oct 1992
VEGA DENTAL OPERATING LIGHT
K854646 · Alpine Dental Equipment Co. · Mar 1986
SURGICAL HEADLIGHT
K842515 · Good-Lite Co. · Aug 1984
ISOLIGHT
K842358 · Planmeca USA, Inc. · Jul 1984
FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS
K822265 · Kelleher Corp. · Sep 1982
K893458 · FIBEROPTIC HEADLIGHT SYSTEM
Download PDF Cuda Products Co.