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FDA 510(k)

Delight, Delight ortho, B&Lite S

K-Number: K170529 · 2017-08-08

Decision Date2017-08-08
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Delight, Delight ortho, B&Lite S is the device name listed in this FDA 510(k) record. The listed applicant is Dentall Co., Ltd.. It received FDA 510(k) clearance on 2017-08-08 under 510(k) 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. The listed applicant is Dentall Co., Ltd.. The 510(k) number is K170529.

When did Delight, Delight ortho, B&Lite S receive FDA 510(k) clearance?

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

Who is the listed applicant for Delight, Delight ortho, B&Lite S?

The FDA 510(k) record lists Dentall Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: EBZ)

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.

Official Source

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