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FDA 510(k)

REPRODENT

K-Number: K790325 · 1979-03-02

ApplicantPremier Dental Products Co.
Decision Date1979-03-02
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REPRODENT is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Co.. It received FDA 510(k) clearance on 1979-03-02 under 510(k) number K790325. 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 REPRODENT?

REPRODENT is a medical device that received FDA 510(k) clearance on 1979-03-02. The listed applicant is Premier Dental Products Co.. The 510(k) number is K790325.

When did REPRODENT receive FDA 510(k) clearance?

REPRODENT received FDA 510(k) clearance on 1979-03-02, under 510(k) number K790325.

Who is the listed applicant for REPRODENT?

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

What is the FDA product code for REPRODENT?

The FDA product code for REPRODENT is EBI.

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Other records listing Premier Dental Products 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.

K132526KNIT-PAK+K131212PREMIER CERAMIC PRIMERK083695TRAXODENTK062166ENAMEL PROK062683ENAMEL PRO VARNISHK061998PREMIER SELF-ETCHING BOND ENHANCER

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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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