510(k) K240714
K240714 is an FDA 510(k) premarket notification submitted by Cosmedent, Inc. for the device "Insure® Universal; Insure® Universal Automix". The FDA issued a decision of Substantially Equivalent on Jul 24, 2024. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Cosmedent, Inc. has 27 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2024
- Date Received
- Mar 15, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type
- 510(k)