BTI Interna Dental Implant System UnicCa - Prosthetic Components— 510(k) K213106

Name: FDA 510(k) clearance K213106
Creator: U.S. Food and Drug Administration
Published: 2022-10-20

Substantially Equivalent

B.T.I. Biotechnology Institute, Sl.

FDA 510(k) clearance K213106 for BTI Interna Dental Implant System UnicCa - Prosthetic Components, Substantially Equivalent on 2022-10-20. Applicant: B.T.I. Biotechnology Institute, Sl.. Device class: 2.

Clearance details

Applicant: B.T.I. Biotechnology Institute, Sl.
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2021-09-24
Decision date: 2022-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minano, ES

Download summary PDF View on FDA.gov ↗

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K231827 — BTI Dental Implant System UnicCa® Aesthetic Post Abutments2023-09-15
K211952 — BTI Interna Narrow/Plus Dental Implant System UnicCa2022-07-21
K202825 — BTI Extra-Short Dental Implant System UnicCa2021-07-29

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.