SYLVAN DENTAL HEADLIGHT SYSTEM— 510(k) K923949

Name: FDA 510(k) clearance K923949
Creator: U.S. Food and Drug Administration
Published: 1992-10-16

Substantially Equivalent

Sylvan Medical Fiberoptics

FDA 510(k) clearance K923949 for SYLVAN DENTAL HEADLIGHT SYSTEM, Substantially Equivalent on 1992-10-16. Applicant: Sylvan Medical Fiberoptics. Device class: 1.

Clearance details

Applicant: Sylvan Medical Fiberoptics
Product code: Code EBA
Device class: Class 1
Regulation: 21 CFR 872.4630
Advisory panel: Dental
Date received: 1992-08-05
Decision date: 1992-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Huntingdon, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBA

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K070287 — PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS5002007-02-12
K893458 — FIBEROPTIC HEADLIGHT SYSTEM1989-06-22
K854646 — VEGA DENTAL OPERATING LIGHT1986-03-06
K842515 — SURGICAL HEADLIGHT1984-08-02
K842358 — ISOLIGHT1984-07-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.