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FDA 510(k)

Endoform Dental Membrane

K-Number: K231305 · 2024-01-23

ApplicantAroa Biosurgery , Ltd.
Decision Date2024-01-23
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Endoform Dental Membrane is a medical device manufactured by Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2024-01-23 under approval number K231305. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoform Dental Membrane?

Endoform Dental Membrane is a medical device that received FDA 510(k) clearance on 2024-01-23. It is manufactured by Aroa Biosurgery , Ltd.. The 510(k) number is K231305.

When was Endoform Dental Membrane approved by the FDA?

Endoform Dental Membrane received FDA 510(k) clearance on 2024-01-23, under approval number K231305.

What company makes Endoform Dental Membrane?

Endoform Dental Membrane is manufactured by Aroa Biosurgery , Ltd..

What is the FDA product code for Endoform Dental Membrane?

The FDA product code for Endoform Dental Membrane is NPL.

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Related Devices (Code: NPL)

K160281OSSIX PLUSDatum Dental, Ltd. K153549OSSIX VOLUMAXDatum Dental, Ltd. K160474DSM Biomedical Porcine Pericardium Dental MembraneKensey Nash Corporation Dba Dsm Biomedical K171050Geistlich Fibro-GideGeistlich Pharma AG K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG K161762DynaMatrix/Dynamatrix PlusCook Biotech Incorporated

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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