K233954
- 510(k) number
- K233954
- Device name
- Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
- Applicant
- B&E Korea Co., Ltd. KR
- Product code
- ELW — Material, Impression
- Decision date
- 2024-02-13
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233954.pdf
Official FDA record: K233954
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.