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

FDA 510(k)

Minitube Dentasleeve Protective Barrier Sleeves

K-Number: K211026 · 2021-08-03

ApplicantMinitube AB
Decision Date2021-08-03
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Minitube Dentasleeve Protective Barrier Sleeves is a medical device manufactured by Minitube AB. It received FDA 510(k) clearance on 2021-08-03 under approval number K211026. 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 Minitube Dentasleeve Protective Barrier Sleeves?

Minitube Dentasleeve Protective Barrier Sleeves is a medical device that received FDA 510(k) clearance on 2021-08-03. It is manufactured by Minitube AB. The 510(k) number is K211026.

When was Minitube Dentasleeve Protective Barrier Sleeves approved by the FDA?

Minitube Dentasleeve Protective Barrier Sleeves received FDA 510(k) clearance on 2021-08-03, under approval number K211026.

What company makes Minitube Dentasleeve Protective Barrier Sleeves?

Minitube Dentasleeve Protective Barrier Sleeves is manufactured by Minitube AB.

What is the FDA product code for Minitube Dentasleeve Protective Barrier Sleeves?

The FDA product code for Minitube Dentasleeve Protective Barrier Sleeves is PEM.

Related Clinical Trials

NCT07562971 Focused Ultrasound Blood-Brain Barrier Opening in Pontine Diffuse Midline Glioma to Enhance Temozolomide Therapy: Pilot Feasibility Study (FIDES) NOT_YET_RECRUITING NCT06984484 Performance and Safety of Afluxin® in Patients With Gastroesophageal Reflux Disease RECRUITING NCT07041671 Evaluation Viral RNA and Virus Infectivity in Exhaled Air Before and After Use of One Dose With ColdZyme Mouth Spray RECRUITING NCT06681012 Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome RECRUITING

Related Devices (Code: PEM)

K160232Disposable Barrier Sleeves and CoversDentsply International, Inc. K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPac-Dent International, Inc. K163447Premium Plus Disposable Barrier SleevePremium Plus International Limited K191448Barrier SleevesIvoclar Vivadent, AG K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd. K190949ScanX Barrier EnvelopesAir Techniques, 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.

↑