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FDA 510(k)

ENLIGHT-2

K-Number: K984217 · 1999-01-20

ApplicantSybron Dental Specialties, Inc.
Decision Date1999-01-20
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENLIGHT-2 is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1999-01-20 under 510(k) number K984217. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENLIGHT-2?

ENLIGHT-2 is a medical device that received FDA 510(k) clearance on 1999-01-20. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K984217.

When did ENLIGHT-2 receive FDA 510(k) clearance?

ENLIGHT-2 received FDA 510(k) clearance on 1999-01-20, under 510(k) number K984217.

Who is the listed applicant for ENLIGHT-2?

The FDA 510(k) record lists Sybron Dental Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENLIGHT-2?

The FDA product code for ENLIGHT-2 is DYH.

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Official Source

View on FDA Database →

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

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