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FDA 510(k)

3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix

K-Number: K212541 · 2022-01-10

ApplicantDeltamed GmbH
Decision Date2022-01-10
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix is a medical device manufactured by Deltamed GmbH. It received FDA 510(k) clearance on 2022-01-10 under approval number K212541. 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 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix?

3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix is a medical device that received FDA 510(k) clearance on 2022-01-10. It is manufactured by Deltamed GmbH. The 510(k) number is K212541.

When was 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix approved by the FDA?

3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix received FDA 510(k) clearance on 2022-01-10, under approval number K212541.

What company makes 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix?

3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix is manufactured by Deltamed GmbH.

What is the FDA product code for 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix?

The FDA product code for 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix is EBI.

Other Devices by Deltamed GmbH

K200039P pro Crown & Bridge K2118043Delta Crown K230341ACRIFIX K2437203Delta UNlimited

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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