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FDA 510(k)

Twilite Appliance

K-Number: K190687 · 2019-07-02

ApplicantStephen J Harkins, Dds, PC
Decision Date2019-07-02
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Twilite Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Stephen J Harkins, Dds, PC. It received FDA 510(k) clearance on 2019-07-02 under 510(k) number K190687. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Twilite Appliance?

Twilite Appliance is a medical device that received FDA 510(k) clearance on 2019-07-02. The listed applicant is Stephen J Harkins, Dds, PC. The 510(k) number is K190687.

When did Twilite Appliance receive FDA 510(k) clearance?

Twilite Appliance received FDA 510(k) clearance on 2019-07-02, under 510(k) number K190687.

Who is the listed applicant for Twilite Appliance?

The FDA 510(k) record lists Stephen J Harkins, Dds, PC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Twilite Appliance?

The FDA product code for Twilite Appliance is LRK.

Related Devices (Code: LRK)

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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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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