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 a medical device manufactured by Datum Dental, Ltd.. It received FDA 510(k) clearance on 2017-07-18 under approval 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. It is manufactured by Datum Dental, Ltd.. The 510(k) number is K163714.

When was OSSIX BONE approved by the FDA?

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

What company makes OSSIX BONE?

OSSIX BONE is manufactured by Datum Dental, Ltd..

What is the FDA product code for OSSIX BONE?

The FDA product code for OSSIX BONE is NPM.

Other Devices by Datum Dental, Ltd.

K160281OSSIX PLUS K153549OSSIX VOLUMAX K212509OSSIX Breeze

Related Devices (Code: NPM)

K151542A-OssHiossen, Inc. K171008Anorganic Bone Mineral with Collagen in Delivery ApplicatorCollagen Matrix, Inc. K170541Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc. K170245DSM Biomedical Dental Bone GraftKensey Nash Corporation Dba Dsm Biomedical K162158Porcine Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc. K173594Straumann ceraboneInstitut Straumann AG

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.