K250473
- 510(k) number
- K250473
- Device name
- Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
- Applicant
- Dci International, LLC OR · US
- Product code
- EIA — Unit, Operative Dental
- Decision date
- 2025-02-19
- Date received
- 2025-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250473
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.