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)

BTI Interna Prosthetic Components

K-Number: K232750 · 2023-12-08

ApplicantB.T.I. Biotechnology Institute, Sl.
Decision Date2023-12-08
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BTI Interna Prosthetic Components is a medical device manufactured by B.T.I. Biotechnology Institute, Sl.. It received FDA 510(k) clearance on 2023-12-08 under approval number K232750. 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 BTI Interna Prosthetic Components?

BTI Interna Prosthetic Components is a medical device that received FDA 510(k) clearance on 2023-12-08. It is manufactured by B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K232750.

When was BTI Interna Prosthetic Components approved by the FDA?

BTI Interna Prosthetic Components received FDA 510(k) clearance on 2023-12-08, under approval number K232750.

What company makes BTI Interna Prosthetic Components?

BTI Interna Prosthetic Components is manufactured by B.T.I. Biotechnology Institute, Sl..

What is the FDA product code for BTI Interna Prosthetic Components?

The FDA product code for BTI Interna Prosthetic Components is NHA.

Related Clinical Trials

NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING

Other Devices by B.T.I. Biotechnology Institute, Sl.

K151391BTI Dental Implant System UnicCa K173257BTI Dental Implant System UnicCa K202825BTI Extra-Short Dental Implant System UnicCa K213106BTI Interna Dental Implant System UnicCa - Prosthetic Components K211952BTI Interna Narrow/Plus Dental Implant System UnicCa K231827BTI Dental Implant System UnicCa® – Aesthetic Post Abutments

View all 8 devices →

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.

↑