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FDA 510(k)

CREDENT RADIOPAQUE DENTURE RESIN

K-Number: K842477 · 1984-12-03

ApplicantCredent Co.
Decision Date1984-12-03
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CREDENT RADIOPAQUE DENTURE RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Credent Co.. It received FDA 510(k) clearance on 1984-12-03 under 510(k) number K842477. 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 CREDENT RADIOPAQUE DENTURE RESIN?

CREDENT RADIOPAQUE DENTURE RESIN is a medical device that received FDA 510(k) clearance on 1984-12-03. The listed applicant is Credent Co.. The 510(k) number is K842477.

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

CREDENT RADIOPAQUE DENTURE RESIN received FDA 510(k) clearance on 1984-12-03, under 510(k) number K842477.

Who is the listed applicant for CREDENT RADIOPAQUE DENTURE RESIN?

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

What is the FDA product code for CREDENT RADIOPAQUE DENTURE RESIN?

The FDA product code for CREDENT RADIOPAQUE DENTURE RESIN is EBI.

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Other records listing Credent Co. 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.

K844670KORVIN VITA RADIOPAQUE PLASTIC TEETHK842476CREDENT RADIOPAQUE CROWN & BRIDE

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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