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

FDA 510(k)

BTI Interna Dental Implant System UnicCa - Prosthetic Components

K-Number: K213106 · 2022-10-20

ApplicantB.T.I. Biotechnology Institute, Sl.
Decision Date2022-10-20
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BTI Interna Dental Implant System UnicCa - Prosthetic Components is the device name listed in this FDA 510(k) record. The listed applicant is B.T.I. Biotechnology Institute, Sl.. It received FDA 510(k) clearance on 2022-10-20 under 510(k) number K213106. 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 Dental Implant System UnicCa - Prosthetic Components?

BTI Interna Dental Implant System UnicCa - Prosthetic Components is a medical device that received FDA 510(k) clearance on 2022-10-20. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K213106.

When did BTI Interna Dental Implant System UnicCa - Prosthetic Components receive FDA 510(k) clearance?

BTI Interna Dental Implant System UnicCa - Prosthetic Components received FDA 510(k) clearance on 2022-10-20, under 510(k) number K213106.

Who is the listed applicant for BTI Interna Dental Implant System UnicCa - Prosthetic Components?

The FDA 510(k) record lists B.T.I. Biotechnology Institute, Sl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BTI Interna Dental Implant System UnicCa - Prosthetic Components?

The FDA product code for BTI Interna Dental Implant System UnicCa - Prosthetic Components is NHA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07638969Occurrence of Peri-Implant Complications: A Multifactorial Cross-Sectional StudyRECRUITINGNCT03528330Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.COMPLETEDNCT05859113Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic ConnectionACTIVE_NOT_RECRUITINGNCT07212855Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge ProtocolCOMPLETEDNCT07744776Effect of Implant Macro-Design and Surface Treatment on Insertion Torque and Early Implant Stability Quotient (ISQ)RECRUITING

Other records listing B.T.I. Biotechnology Institute, Sl. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240262BTI Interna 3.0 Dental Implant System UnicCa®K232750BTI Interna Prosthetic ComponentsK231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsK211952BTI Interna Narrow/Plus Dental Implant System UnicCaK202825BTI Extra-Short Dental Implant System UnicCaK173257BTI Dental Implant System UnicCa

View all 8 devices →

Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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.

↑