FDA 510(k)

PacEndo EDTA

K-Number: K153528 · 2016-02-01

Decision Date2016-02-01

Product CodeKJJ

DecisionSubstantially Equivalent

Device Summary

PacEndo EDTA 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 2016-02-01 under 510(k) number K153528. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PacEndo EDTA?

PacEndo EDTA is a medical device that received FDA 510(k) clearance on 2016-02-01. The listed applicant is Pac-Dent International, Inc.. The 510(k) number is K153528.

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

PacEndo EDTA received FDA 510(k) clearance on 2016-02-01, under 510(k) number K153528.

Who is the listed applicant for PacEndo EDTA?

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 EDTA?

The FDA product code for PacEndo EDTA 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 Paste K160577PacEndo Chlorhexidine K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film

Related Devices (Code: KJJ)

K250279RC-SwiftPrepBelport Company, Inc., Gingi-Pak K241354Sealer SolventInter-Med, Inc.K201785EPIEN Dental CleanserEpien Medical, Inc.K211813TritonInter-Med / Vista Dental K193357V-MixInter-Med/Vista Dental Products K193409Vista 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.