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FDA 510(k)

Dentca Denture Base II

K-Number: K162044 · 2017-03-03

ApplicantDentca, Inc.
Decision Date2017-03-03
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentca Denture Base II is the device name listed in this FDA 510(k) record. The listed applicant is Dentca, Inc.. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K162044. 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 Dentca Denture Base II?

Dentca Denture Base II is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Dentca, Inc.. The 510(k) number is K162044.

When did Dentca Denture Base II receive FDA 510(k) clearance?

Dentca Denture Base II received FDA 510(k) clearance on 2017-03-03, under 510(k) number K162044.

Who is the listed applicant for Dentca Denture Base II?

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

What is the FDA product code for Dentca Denture Base II?

The FDA product code for Dentca Denture Base II is EBI.

Other records listing Dentca, Inc. 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.

K261474DENTCA Tru FlexibleK220042Dentca Base Premium, Dentca Base Hi-ImpactK192806DENTCA Crown and BridgeK172398DENTCA DENTURE Teeth

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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