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FDA 510(k)

PREMIER CARVERS, STYLE #21C & 21D

K-Number: K780528 · 1978-04-19

ApplicantPremier Dental Products Co.
Decision Date1978-04-19
Product CodeEKH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIER CARVERS, STYLE #21C & 21D 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 1978-04-19 under 510(k) number K780528. The device is classified under product code EKH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER CARVERS, STYLE #21C & 21D?

PREMIER CARVERS, STYLE #21C & 21D is a medical device that received FDA 510(k) clearance on 1978-04-19. The listed applicant is Premier Dental Products Co.. The 510(k) number is K780528.

When did PREMIER CARVERS, STYLE #21C & 21D receive FDA 510(k) clearance?

PREMIER CARVERS, STYLE #21C & 21D received FDA 510(k) clearance on 1978-04-19, under 510(k) number K780528.

Who is the listed applicant for PREMIER CARVERS, STYLE #21C & 21D?

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 PREMIER CARVERS, STYLE #21C & 21D?

The FDA product code for PREMIER CARVERS, STYLE #21C & 21D is EKH.

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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 PRIMERK083695TRAXODENTK062683ENAMEL PRO VARNISHK062166ENAMEL PROK061997PREMIER SELF-ETCHING ENAMEL SEALANT

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Related Devices (Code: EKH)

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.

K823321DENTAL INSTRUMENTS - CARVERMiltex, Inc.K821785BEACH AMALGAM CARVERPacific Dental Corp.

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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