MC BIO Supertack Tack 3mm, 4mm and 5mm— 510(k) K151540
Substantially EquivalentEli-Ka Technologies
FDA 510(k) clearance K151540 for MC BIO Supertack Tack 3mm, 4mm and 5mm, Substantially Equivalent on 2016-05-26. Applicant: Eli-Ka Technologies.
Clearance details
- Applicant
- Eli-Ka Technologies
- Product code
- Code DZL
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monrovia, CA, US
Adverse events under product code DZL
product code DZL- Injury
- 168
- Total
- 168
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.