Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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 2016-03-03 under 510(k) 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. The listed applicant is Pac-Dent International, Inc.. The 510(k) number is K151123.

When did Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film receive FDA 510(k) clearance?

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

Who is the listed applicant for Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film?

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 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.

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 PasteK160577PacEndo ChlorhexidineK153528PacEndo EDTA

Related Devices (Code: PEM)

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.

K250735Dental Barrier and SleevesFomed Industries, Inc.K250606Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd.K242435Dental Barrier and SleevesWellmed Dental Medical Supply Co., Ltd.K233918Dental Barrier and SleevesYongqing Huaguan Dental Instruments FactoryK220662Disposable Barrier SleevesPremium Plus (Dongguan) LimitedK211026Minitube Dentasleeve Protective Barrier SleevesMinitube AB

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.

↑