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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 a medical device manufactured by Dentca, Inc.. It received FDA 510(k) clearance on 2017-03-03 under approval 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. It is manufactured by Dentca, Inc.. The 510(k) number is K162044.

When was Dentca Denture Base II approved by the FDA?

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

What company makes Dentca Denture Base II?

Dentca Denture Base II is manufactured by Dentca, Inc..

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

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

Other Devices by Dentca, Inc.

K172398DENTCA DENTURE Teeth K192806DENTCA Crown and Bridge K220042Dentca Base Premium, Dentca Base Hi-Impact

Related Devices (Code: EBI)

K161330Pour AcrylicDentsply Sirona K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry K152981JET SET 4 DENTURE REPAIR RESINLang Dental Manufacturing Company, Inc. K160498Dentivera Milling DiscDental Solutions, LLC K153590AvaDent Denture Base MaterialGlobal Dental Science K152051ClearMetMycone Dental Supply Co., T/A Keystone Industries

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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