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FDA 510(k)

OSSIX VOLUMAX

K-Number: K153549 · 2016-08-04

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

Device Summary

OSSIX VOLUMAX is a medical device manufactured by Datum Dental, Ltd.. It received FDA 510(k) clearance on 2016-08-04 under approval number K153549. 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 VOLUMAX?

OSSIX VOLUMAX 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 K153549.

When was OSSIX VOLUMAX approved by the FDA?

OSSIX VOLUMAX received FDA 510(k) clearance on 2016-08-04, under approval number K153549.

What company makes OSSIX VOLUMAX?

OSSIX VOLUMAX is manufactured by Datum Dental, Ltd..

What is the FDA product code for OSSIX VOLUMAX?

The FDA product code for OSSIX VOLUMAX is NPL.

Other Devices by Datum Dental, Ltd.

K160281OSSIX PLUS K163714OSSIX BONE K212509OSSIX Breeze

Related Devices (Code: NPL)

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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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