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FDA 510(k)

OSSIX PLUS

K-Number: K160281 · 2016-08-04

ApplicantDatum Dental, Ltd.
Decision Date2016-08-04
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSIX PLUS 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 2016-08-04 under 510(k) number K160281. 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 PLUS?

OSSIX PLUS is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Datum Dental, Ltd.. The 510(k) number is K160281.

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

OSSIX PLUS received FDA 510(k) clearance on 2016-08-04, under 510(k) number K160281.

Who is the listed applicant for OSSIX PLUS?

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 PLUS?

The FDA product code for OSSIX PLUS 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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