BB Base 3D printing resin for denture base— 510(k) K191591
Substantially EquivalentEnlighten Materials Co., Ltd.
FDA 510(k) clearance K191591 for BB Base 3D printing resin for denture base, Substantially Equivalent on 2020-08-18. Applicant: Enlighten Materials Co., Ltd..
Clearance details
- Applicant
- Enlighten Materials Co., Ltd.
- Product code
- Code EBI
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei, TW
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.