K232978
- 510(k) number
- K232978
- Device name
- DX. Bond V Dental Bonding Adhesive
- Applicant
- Sino-Dentex Co., Ltd. MN · US
- Product code
- KLE — Agent, Tooth Bonding, Resin
- Decision date
- 2023-09-22
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K232978.pdf
Official FDA record: K232978
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.