K242884
- 510(k) number
- K242884
- Device name
- Additively Manufactured Denture Resin
- Applicant
- Aidite (Qinhuangdao) Technology Co., Ltd. CN
- Product code
- EBI — Resin, Denture, Relining, Repairing, Rebasing
- Decision date
- 2024-11-22
- Date received
- 2024-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242884.pdf
Official FDA record: K242884
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.