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FDA 510(k)

Dentca Base Premium, Dentca Base Hi-Impact

K-Number: K220042 · 2022-11-17

ApplicantDentca, Inc.
Decision Date2022-11-17
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentca Base Premium, Dentca Base Hi-Impact is a medical device manufactured by Dentca, Inc.. It received FDA 510(k) clearance on 2022-11-17 under approval number K220042. 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 Base Premium, Dentca Base Hi-Impact?

Dentca Base Premium, Dentca Base Hi-Impact is a medical device that received FDA 510(k) clearance on 2022-11-17. It is manufactured by Dentca, Inc.. The 510(k) number is K220042.

When was Dentca Base Premium, Dentca Base Hi-Impact approved by the FDA?

Dentca Base Premium, Dentca Base Hi-Impact received FDA 510(k) clearance on 2022-11-17, under approval number K220042.

What company makes Dentca Base Premium, Dentca Base Hi-Impact?

Dentca Base Premium, Dentca Base Hi-Impact is manufactured by Dentca, Inc..

What is the FDA product code for Dentca Base Premium, Dentca Base Hi-Impact?

The FDA product code for Dentca Base Premium, Dentca Base Hi-Impact is EBI.

Other Devices by Dentca, Inc.

K172398DENTCA DENTURE Teeth K162044Dentca Denture Base II K192806DENTCA Crown and Bridge

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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