JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White— 510(k) K181331
Substantially EquivalentJuvora, Ltd.
FDA 510(k) clearance K181331 for JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White, Substantially Equivalent on 2018-12-21. Applicant: Juvora, Ltd..
Clearance details
- Applicant
- Juvora, Ltd.
- Product code
- Code EBI
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Thornton-Clevelys, GB
Adverse events under product code EBI
product code EBI- 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.