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FDA 510(k)

Bonafix 2 Plus

K-Number: K213677 · 2022-12-20

ApplicantZentek Medical, LLC
Decision Date2022-12-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bonafix 2 Plus is a medical device manufactured by Zentek Medical, LLC. It received FDA 510(k) clearance on 2022-12-20 under approval number K213677. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bonafix 2 Plus?

Bonafix 2 Plus is a medical device that received FDA 510(k) clearance on 2022-12-20. It is manufactured by Zentek Medical, LLC. The 510(k) number is K213677.

When was Bonafix 2 Plus approved by the FDA?

Bonafix 2 Plus received FDA 510(k) clearance on 2022-12-20, under approval number K213677.

What company makes Bonafix 2 Plus?

Bonafix 2 Plus is manufactured by Zentek Medical, LLC.

What is the FDA product code for Bonafix 2 Plus?

The FDA product code for Bonafix 2 Plus is DZE.

Other Devices by Zentek Medical, LLC

K221673Bonafix TiBase K251294Bonafix Implant Abutments

Related Devices (Code: DZE)

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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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