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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 a medical device manufactured by Datum Dental, Ltd.. It received FDA 510(k) clearance on 2016-08-04 under approval 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. It is manufactured by Datum Dental, Ltd.. The 510(k) number is K160281.

When was OSSIX PLUS approved by the FDA?

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

What company makes OSSIX PLUS?

OSSIX PLUS is manufactured by Datum Dental, Ltd..

What is the FDA product code for OSSIX PLUS?

The FDA product code for OSSIX PLUS is NPL.

Other Devices by Datum Dental, Ltd.

K153549OSSIX VOLUMAX K163714OSSIX BONE K212509OSSIX Breeze

Related Devices (Code: NPL)

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 K173562Straumann Jason MembraneInstitut Straumann AG

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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