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FDA 510(k)

DENTAL IMPRESSION SYINGE

K-Number: K890357 · 1989-02-13

ApplicantInnotek Dental Corp.
Decision Date1989-02-13
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL IMPRESSION SYINGE is the device name listed in this FDA 510(k) record. The listed applicant is Innotek Dental Corp.. It received FDA 510(k) clearance on 1989-02-13 under 510(k) number K890357. 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 DENTAL IMPRESSION SYINGE?

DENTAL IMPRESSION SYINGE is a medical device that received FDA 510(k) clearance on 1989-02-13. The listed applicant is Innotek Dental Corp.. The 510(k) number is K890357.

When did DENTAL IMPRESSION SYINGE receive FDA 510(k) clearance?

DENTAL IMPRESSION SYINGE received FDA 510(k) clearance on 1989-02-13, under 510(k) number K890357.

Who is the listed applicant for DENTAL IMPRESSION SYINGE?

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

What is the FDA product code for DENTAL IMPRESSION SYINGE?

The FDA product code for DENTAL IMPRESSION SYINGE is EKJ.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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