FDA 510(k)

OsteoSync Ti Dental Mesh

K-Number: K202918 · 2021-07-14

Decision Date2021-07-14

Product CodeJEY

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

OsteoSync Ti Dental Mesh is a medical device manufactured by Sites Medical, LLC. It received FDA 510(k) clearance on 2021-07-14 under approval number K202918. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoSync Ti Dental Mesh?

OsteoSync Ti Dental Mesh is a medical device that received FDA 510(k) clearance on 2021-07-14. It is manufactured by Sites Medical, LLC. The 510(k) number is K202918.

When was OsteoSync Ti Dental Mesh approved by the FDA?

OsteoSync Ti Dental Mesh received FDA 510(k) clearance on 2021-07-14, under approval number K202918.

What company makes OsteoSync Ti Dental Mesh?

OsteoSync Ti Dental Mesh is manufactured by Sites Medical, LLC.

What is the FDA product code for OsteoSync Ti Dental Mesh?

The FDA product code for OsteoSync Ti Dental Mesh is JEY.

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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.