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FDA 510(k)

DISPOSABLE DENTAL PROBE/EXPLORER

K-Number: K880590 · 1988-03-02

ApplicantBaxter Healthcare Corp
Decision Date1988-03-02
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE DENTAL PROBE/EXPLORER is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1988-03-02 under 510(k) number K880590. 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 DISPOSABLE DENTAL PROBE/EXPLORER?

DISPOSABLE DENTAL PROBE/EXPLORER is a medical device that received FDA 510(k) clearance on 1988-03-02. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K880590.

When did DISPOSABLE DENTAL PROBE/EXPLORER receive FDA 510(k) clearance?

DISPOSABLE DENTAL PROBE/EXPLORER received FDA 510(k) clearance on 1988-03-02, under 510(k) number K880590.

Who is the listed applicant for DISPOSABLE DENTAL PROBE/EXPLORER?

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

What is the FDA product code for DISPOSABLE DENTAL PROBE/EXPLORER?

The FDA product code for DISPOSABLE DENTAL PROBE/EXPLORER is EKJ.

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Other records listing Baxter Healthcare Corp as applicant

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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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