BTI Dental Implant System UnicCa— 510(k) K173257
Substantially EquivalentB.T.I. Biotechnology Institute, Sl.
FDA 510(k) clearance K173257 for BTI Dental Implant System UnicCa, Substantially Equivalent on 2018-08-17. Applicant: B.T.I. Biotechnology Institute, Sl.. Device class: 2.
Clearance details
- Applicant
- B.T.I. Biotechnology Institute, Sl.
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minano, ES
Recent devices under product code DZE
view allMore clearances from B.T.I. Biotechnology Institute, Sl.
view all- K240262 — BTI Interna 3.0 Dental Implant System UnicCa®
- K232750 — BTI Interna Prosthetic Components
- K231827 — BTI Dental Implant System UnicCa® Aesthetic Post Abutments
- K213106 — BTI Interna Dental Implant System UnicCa - Prosthetic Components
- K211952 — BTI Interna Narrow/Plus Dental Implant System UnicCa
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . 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.