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FDA 510(k)

PacEndo Chlorhexidine

K-Number: K160577 · 2016-07-25

ApplicantPac-Dent International, Inc.
Decision Date2016-07-25
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

PacEndo Chlorhexidine is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent International, Inc.. It received FDA 510(k) clearance on 2016-07-25 under 510(k) number K160577. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PacEndo Chlorhexidine?

PacEndo Chlorhexidine is a medical device that received FDA 510(k) clearance on 2016-07-25. The listed applicant is Pac-Dent International, Inc.. The 510(k) number is K160577.

When did PacEndo Chlorhexidine receive FDA 510(k) clearance?

PacEndo Chlorhexidine received FDA 510(k) clearance on 2016-07-25, under 510(k) number K160577.

Who is the listed applicant for PacEndo Chlorhexidine?

The FDA 510(k) record lists Pac-Dent International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PacEndo Chlorhexidine?

The FDA product code for PacEndo Chlorhexidine is KJJ.

Other records listing Pac-Dent International, Inc. 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.

K162662GingiDent Gingival Retraction PasteK151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmK153528PacEndo EDTA

Related Devices (Code: KJJ)

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.

K250279RC-SwiftPrepBelport Company, Inc., Gingi-PakK241354Sealer SolventInter-Med, Inc.K201785EPIEN Dental CleanserEpien Medical, Inc.K211813TritonInter-Med / Vista DentalK193357V-MixInter-Med/Vista Dental ProductsK193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products

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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