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FDA 510(k)

DD medical polymers (PMMA)

K-Number: K230410 · 2023-06-23

ApplicantDental Direkt GmbH
Decision Date2023-06-23
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DD medical polymers (PMMA) is the device name listed in this FDA 510(k) record. The listed applicant is Dental Direkt GmbH. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K230410. 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 DD medical polymers (PMMA)?

DD medical polymers (PMMA) is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Dental Direkt GmbH. The 510(k) number is K230410.

When did DD medical polymers (PMMA) receive FDA 510(k) clearance?

DD medical polymers (PMMA) received FDA 510(k) clearance on 2023-06-23, under 510(k) number K230410.

Who is the listed applicant for DD medical polymers (PMMA)?

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

What is the FDA product code for DD medical polymers (PMMA)?

The FDA product code for DD medical polymers (PMMA) is EBI.

Other records listing Dental Direkt 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.

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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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