Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bonafix TiBase

K-Number: K221673 · 2023-07-14

ApplicantZentek Medical, LLC
Decision Date2023-07-14
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bonafix TiBase is a medical device manufactured by Zentek Medical, LLC. It received FDA 510(k) clearance on 2023-07-14 under approval number K221673. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bonafix TiBase?

Bonafix TiBase is a medical device that received FDA 510(k) clearance on 2023-07-14. It is manufactured by Zentek Medical, LLC. The 510(k) number is K221673.

When was Bonafix TiBase approved by the FDA?

Bonafix TiBase received FDA 510(k) clearance on 2023-07-14, under approval number K221673.

What company makes Bonafix TiBase?

Bonafix TiBase is manufactured by Zentek Medical, LLC.

What is the FDA product code for Bonafix TiBase?

The FDA product code for Bonafix TiBase is NHA.

Other Devices by Zentek Medical, LLC

K213677Bonafix 2 Plus K251294Bonafix Implant Abutments

Related Devices (Code: NHA)

K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, Inc.

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.

↑