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FDA 510(k)

ASEPTIP

K-Number: K882399 · 1988-06-21

ApplicantKoppa Innovative Dental Products, Inc.
Decision Date1988-06-21
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ASEPTIP is the device name listed in this FDA 510(k) record. The listed applicant is Koppa Innovative Dental Products, Inc.. It received FDA 510(k) clearance on 1988-06-21 under 510(k) number K882399. 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 ASEPTIP?

ASEPTIP is a medical device that received FDA 510(k) clearance on 1988-06-21. The listed applicant is Koppa Innovative Dental Products, Inc.. The 510(k) number is K882399.

When did ASEPTIP receive FDA 510(k) clearance?

ASEPTIP received FDA 510(k) clearance on 1988-06-21, under 510(k) number K882399.

Who is the listed applicant for ASEPTIP?

The FDA 510(k) record lists Koppa Innovative Dental Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASEPTIP?

The FDA product code for ASEPTIP is EKJ.

Related Clinical Trials

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.

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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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