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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 the device name listed in this FDA 510(k) record. The listed applicant is Datum Dental, Ltd.. It received FDA 510(k) clearance on 2022-07-18 under 510(k) 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. The listed applicant is Datum Dental, Ltd.. The 510(k) number is K212509.

When did OSSIX Breeze receive FDA 510(k) clearance?

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

Who is the listed applicant for OSSIX Breeze?

The FDA 510(k) record lists Datum Dental, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSIX Breeze?

The FDA product code for OSSIX Breeze is NPL.

Other records listing Datum Dental, Ltd. 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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