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FDA 510(k)

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film

K-Number: K151123 · 2016-03-03

ApplicantPac-Dent International, Inc.
Decision Date2016-03-03
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film is a medical device manufactured by Pac-Dent International, Inc.. It received FDA 510(k) clearance on 2016-03-03 under approval number K151123. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film?

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film is a medical device that received FDA 510(k) clearance on 2016-03-03. It is manufactured by Pac-Dent International, Inc.. The 510(k) number is K151123.

When was Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film approved by the FDA?

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film received FDA 510(k) clearance on 2016-03-03, under approval number K151123.

What company makes Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film?

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film is manufactured by Pac-Dent International, Inc..

What is the FDA product code for Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film?

The FDA product code for Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film is PEM.

Related Clinical Trials

NCT07019610 Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial NOT_YET_RECRUITING

Other Devices by Pac-Dent International, Inc.

K160577PacEndo Chlorhexidine K153528PacEndo EDTA K162662GingiDent Gingival Retraction Paste

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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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