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FDA 510(k)

OSSIX Breeze

K-Number: K212509 · 2022-07-18

ApplicantDatum Dental, Ltd.
Decision Date2022-07-18
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSIX Breeze is a medical device manufactured by Datum Dental, Ltd.. It received FDA 510(k) clearance on 2022-07-18 under approval number K212509. 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 OSSIX Breeze?

OSSIX Breeze is a medical device that received FDA 510(k) clearance on 2022-07-18. It is manufactured by Datum Dental, Ltd.. The 510(k) number is K212509.

When was OSSIX Breeze approved by the FDA?

OSSIX Breeze received FDA 510(k) clearance on 2022-07-18, under approval number K212509.

What company makes OSSIX Breeze?

OSSIX Breeze is manufactured by Datum Dental, Ltd..

What is the FDA product code for OSSIX Breeze?

The FDA product code for OSSIX Breeze is NPL.

Other Devices by Datum Dental, Ltd.

K160281OSSIX PLUS K153549OSSIX VOLUMAX K163714OSSIX BONE

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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