K240714
- 510(k) number
- K240714
- Device name
- Insure® Universal; Insure® Universal Automix
- Applicant
- Cosmedent, Inc. IL · US
- Product code
- EMA — Cement, Dental
- Decision date
- 2024-07-24
- Date received
- 2024-03-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K240714
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.