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FDA 510(k)

HARDCOATED PLASTIC FILLING INSTRUMENT

K-Number: K912149 · 1991-06-24

ApplicantPremier Dental Products Co.
Decision Date1991-06-24
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HARDCOATED PLASTIC FILLING INSTRUMENT 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 1991-06-24 under 510(k) number K912149. The device is classified under product code EKJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARDCOATED PLASTIC FILLING INSTRUMENT?

HARDCOATED PLASTIC FILLING INSTRUMENT is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Premier Dental Products Co.. The 510(k) number is K912149.

When did HARDCOATED PLASTIC FILLING INSTRUMENT receive FDA 510(k) clearance?

HARDCOATED PLASTIC FILLING INSTRUMENT received FDA 510(k) clearance on 1991-06-24, under 510(k) number K912149.

Who is the listed applicant for HARDCOATED PLASTIC FILLING INSTRUMENT?

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 HARDCOATED PLASTIC FILLING INSTRUMENT?

The FDA product code for HARDCOATED PLASTIC FILLING INSTRUMENT is EKJ.

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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 VARNISHK061997PREMIER SELF-ETCHING ENAMEL SEALANT

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Related Devices (Code: EKJ)

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.

K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.K953707MEDTROL DENTAL KITMedtrol, Inc.K945815DENTAL KITConstancy Ent., Inc.K951607SUREFLEX FILESDentsply Intl.K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.K943820STAT PAKMagnum Instruments, 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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