BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS— 510(k) K061383
Substantially EquivalentB.T.I. Biotechnology Institute, Sl.
FDA 510(k) clearance K061383 for BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS, Substantially Equivalent on 2006-08-03. Applicant: B.T.I. Biotechnology Institute, Sl.. Device class: 1.
Clearance details
- Applicant
- B.T.I. Biotechnology Institute, Sl.
- Product code
- Code EJL
- Device class
- Class 1
- Regulation
- 21 CFR 872.3240
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minano(Alava), ES
Recent devices under product code EJL
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 EJL
product code EJL- Other
- 1
- Total
- 1
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.