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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 the device name listed in this FDA 510(k) record. The listed applicant is Deltamed GmbH. It received FDA 510(k) clearance on 2022-01-10 under 510(k) 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. The listed applicant is Deltamed GmbH. The 510(k) number is K212541.

When did 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix receive FDA 510(k) clearance?

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

Who is the listed applicant for 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix?

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

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 records listing Deltamed GmbH 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.

K2437203Delta UNlimitedK230341ACRIFIXK2118043Delta CrownK200039P pro Crown & Bridge

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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