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 Dental Implant System UnicCa® – Aesthetic Post Abutments

K-Number: K231827 · 2023-09-15

ApplicantB.T.I. Biotechnology Institute, Sl.
Decision Date2023-09-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments 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 2023-09-15 under 510(k) number K231827. 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 Dental Implant System UnicCa® – Aesthetic Post Abutments?

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K231827.

When did BTI Dental Implant System UnicCa® – Aesthetic Post Abutments receive FDA 510(k) clearance?

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments received FDA 510(k) clearance on 2023-09-15, under 510(k) number K231827.

Who is the listed applicant for BTI Dental Implant System UnicCa® – Aesthetic Post Abutments?

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 Dental Implant System UnicCa® – Aesthetic Post Abutments?

The FDA product code for BTI Dental Implant System UnicCa® – Aesthetic Post Abutments 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.

NCT04695899Zirconia Implants for Replacement of a Single ToothACTIVE_NOT_RECRUITINGNCT05122897Investigation of Biofilm Formation on Temporary push-on Rings of Implant CrownsRECRUITINGNCT05883202Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental ImplantsSUSPENDEDNCT06086873Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLARECRUITINGNCT07212855Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge ProtocolCOMPLETEDNCT07246499Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.COMPLETED

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 ComponentsK213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsK211952BTI 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.

↑