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FDA 510(k)

PacEndo EDTA

K-Number: K153528 · 2016-02-01

ApplicantPac-Dent International, Inc.
Decision Date2016-02-01
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

PacEndo EDTA is a medical device manufactured by Pac-Dent International, Inc.. It received FDA 510(k) clearance on 2016-02-01 under approval 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. It is manufactured by Pac-Dent International, Inc.. The 510(k) number is K153528.

When was PacEndo EDTA approved by the FDA?

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

What company makes PacEndo EDTA?

PacEndo EDTA is manufactured by Pac-Dent International, Inc..

What is the FDA product code for PacEndo EDTA?

The FDA product code for PacEndo EDTA is KJJ.

Other Devices by Pac-Dent International, Inc.

K160577PacEndo Chlorhexidine K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film K162662GingiDent Gingival Retraction Paste

Related Devices (Code: KJJ)

K160577PacEndo ChlorhexidinePac-Dent International, Inc. K162311Straumann PrefGelInstitut Straumann AG K173163ChlorCid, ChlorCid V, ChlorCid SurfUltradent Products, Inc. K193357V-MixInter-Med/Vista Dental Products K193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products K200330RC-Prime Root Canal Preparation CreamPac-Dent, 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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