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FDA 510(k)

DIOnavi-Denture

K-Number: K193623 · 2020-10-22

ApplicantDio Corporation
Decision Date2020-10-22
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIOnavi-Denture is the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2020-10-22 under 510(k) number K193623. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIOnavi-Denture?

DIOnavi-Denture is a medical device that received FDA 510(k) clearance on 2020-10-22. The listed applicant is Dio Corporation. The 510(k) number is K193623.

When did DIOnavi-Denture receive FDA 510(k) clearance?

DIOnavi-Denture received FDA 510(k) clearance on 2020-10-22, under 510(k) number K193623.

Who is the listed applicant for DIOnavi-Denture?

The FDA 510(k) record lists Dio Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIOnavi-Denture?

The FDA product code for DIOnavi-Denture is EBI.

Other records listing Dio Corporation as applicant

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.

K220253Eco Abutment, Multiunit AbutmentK210828DIOnavi-Denture02K193404UF(II) Bar holder abutmentK192263UCLA CCM AbutmentK190048UF(II) Anatomic abutmentK181037DIO CAD/CAM Abutment

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Related Devices (Code: EBI)

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.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

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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