FDA 510(k)

OSSIX BONE

K-Number: K163714 · 2017-07-18

Decision Date2017-07-18

Product CodeNPM

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

OSSIX BONE 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 2017-07-18 under 510(k) number K163714. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSIX BONE?

OSSIX BONE is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Datum Dental, Ltd.. The 510(k) number is K163714.

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

OSSIX BONE received FDA 510(k) clearance on 2017-07-18, under 510(k) number K163714.

Who is the listed applicant for OSSIX BONE?

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 BONE?

The FDA product code for OSSIX BONE is NPM.

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.

K212509OSSIX Breeze K160281OSSIX PLUS K153549OSSIX VOLUMAX

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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.