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FDA 510(k)

MAXUM DENTURE RESIN

K-Number: K800400 · 1980-03-12

ApplicantDentsply Intl.
Decision Date1980-03-12
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAXUM DENTURE RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1980-03-12 under 510(k) number K800400. 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 MAXUM DENTURE RESIN?

MAXUM DENTURE RESIN is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Dentsply Intl.. The 510(k) number is K800400.

When did MAXUM DENTURE RESIN receive FDA 510(k) clearance?

MAXUM DENTURE RESIN received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800400.

Who is the listed applicant for MAXUM DENTURE RESIN?

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

What is the FDA product code for MAXUM DENTURE RESIN?

The FDA product code for MAXUM DENTURE RESIN is EBI.

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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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.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.

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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