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FDA 510(k)

Delight, Delight ortho, B&Lite S

K-Number: K170529 · 2017-08-08

ApplicantDentall Co., Ltd.
Decision Date2017-08-08
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Delight, Delight ortho, B&Lite S is a medical device manufactured by Dentall Co., Ltd.. It received FDA 510(k) clearance on 2017-08-08 under approval number K170529. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Delight, Delight ortho, B&Lite S?

Delight, Delight ortho, B&Lite S is a medical device that received FDA 510(k) clearance on 2017-08-08. It is manufactured by Dentall Co., Ltd.. The 510(k) number is K170529.

When was Delight, Delight ortho, B&Lite S approved by the FDA?

Delight, Delight ortho, B&Lite S received FDA 510(k) clearance on 2017-08-08, under approval number K170529.

What company makes Delight, Delight ortho, B&Lite S?

Delight, Delight ortho, B&Lite S is manufactured by Dentall Co., Ltd..

What is the FDA product code for Delight, Delight ortho, B&Lite S?

The FDA product code for Delight, Delight ortho, B&Lite S is EBZ.

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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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