SMARTBURS— 510(k) K080687
Substantially EquivalentS.S. White Burs, Inc.
FDA 510(k) clearance K080687 for SMARTBURS, Substantially Equivalent on 2008-06-20. Applicant: S.S. White Burs, Inc..
Clearance details
- Applicant
- S.S. White Burs, Inc.
- Product code
- Code EJL
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, NJ, US
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.