OSSIX Breeze

FDA 510(k) K212509 · Datum Dental, Ltd.

Substantially Equivalent

510(k) numberK212509

Submission

Device name
OSSIX Breeze
Applicant
Datum Dental, Ltd.
Lod, IL
Received
August 9, 2021
Decision date
July 18, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NPL – Barrier, Animal Source, Intraoral
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3930
Specialty
Dental
Implant
Yes

An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.

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More from Sigmagraft, Inc.

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K163714Ossix BoneNPM · Traditional 07/18/2017SE
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Questions and answers

When was OSSIX Breeze cleared by the FDA?

OSSIX Breeze (K212509) received a 510(k) decision of Substantially Equivalent on July 18, 2022, 343 days after the submission was received.

What is the product code of K212509?

The FDA product code is NPL – Barrier, Animal Source, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.