BTI Dental Implant System UnicCa® Aesthetic Post Abutments— 510(k) K231827

Name: FDA 510(k) clearance K231827
Creator: U.S. Food and Drug Administration
Published: 2023-09-15

Substantially Equivalent

B.T.I. Biotechnology Institute, Sl.

FDA 510(k) clearance K231827 for BTI Dental Implant System UnicCa® Aesthetic Post Abutments, Substantially Equivalent on 2023-09-15. 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: 2023-06-21
Decision date: 2023-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miñano, ES

Download summary PDF View on FDA.gov ↗

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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.