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FDA 510(k)

SYLVAN DENTAL HEADLIGHT SYSTEM

K-Number: K923949 · 1992-10-16

ApplicantSylvan Medical Fiberoptics
Decision Date1992-10-16
Product CodeEBA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYLVAN DENTAL HEADLIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sylvan Medical Fiberoptics. It received FDA 510(k) clearance on 1992-10-16 under 510(k) number K923949. The device is classified under product code EBA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYLVAN DENTAL HEADLIGHT SYSTEM?

SYLVAN DENTAL HEADLIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 1992-10-16. The listed applicant is Sylvan Medical Fiberoptics. The 510(k) number is K923949.

When did SYLVAN DENTAL HEADLIGHT SYSTEM receive FDA 510(k) clearance?

SYLVAN DENTAL HEADLIGHT SYSTEM received FDA 510(k) clearance on 1992-10-16, under 510(k) number K923949.

Who is the listed applicant for SYLVAN DENTAL HEADLIGHT SYSTEM?

The FDA 510(k) record lists Sylvan Medical Fiberoptics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYLVAN DENTAL HEADLIGHT SYSTEM?

The FDA product code for SYLVAN DENTAL HEADLIGHT SYSTEM is EBA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EBA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K070287PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500Photonic Optische Gerate GmbH & CokgK893458FIBEROPTIC HEADLIGHT SYSTEMCuda Products Co.K854646VEGA DENTAL OPERATING LIGHTAlpine Dental Equipment Co.K842515SURGICAL HEADLIGHTGood-Lite Co.K842358ISOLIGHTPlanmeca USA, Inc.K822265FIBEROPTIC LIGHT SOURCE W/RELATED ITEMSKelleher Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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