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FDA 510(k)

PREMIER INLAY PLACER

K-Number: K781034 · 1978-06-30

ApplicantPremier Dental Products Co.
Decision Date1978-06-30
Product CodeEKI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIER INLAY PLACER 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 1978-06-30 under 510(k) number K781034. The device is classified under product code EKI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER INLAY PLACER?

PREMIER INLAY PLACER is a medical device that received FDA 510(k) clearance on 1978-06-30. The listed applicant is Premier Dental Products Co.. The 510(k) number is K781034.

When did PREMIER INLAY PLACER receive FDA 510(k) clearance?

PREMIER INLAY PLACER received FDA 510(k) clearance on 1978-06-30, under 510(k) number K781034.

Who is the listed applicant for PREMIER INLAY PLACER?

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 INLAY PLACER?

The FDA product code for PREMIER INLAY PLACER is EKI.

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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: EKI)

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.

K945220AMALGAM CARRIERBuffalo Dental Mfg. Co., 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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