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FDA 510(k)

ENLIGHT (TENTATIVE NAME)

K-Number: K972890 · 1997-09-16

ApplicantSybron Dental Specialties, Inc.
Decision Date1997-09-16
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENLIGHT (TENTATIVE NAME) 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 1997-09-16 under 510(k) number K972890. 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 (TENTATIVE NAME)?

ENLIGHT (TENTATIVE NAME) is a medical device that received FDA 510(k) clearance on 1997-09-16. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K972890.

When did ENLIGHT (TENTATIVE NAME) receive FDA 510(k) clearance?

ENLIGHT (TENTATIVE NAME) received FDA 510(k) clearance on 1997-09-16, under 510(k) number K972890.

Who is the listed applicant for ENLIGHT (TENTATIVE NAME)?

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 (TENTATIVE NAME)?

The FDA product code for ENLIGHT (TENTATIVE NAME) 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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