510(k) K254063
K254063 is an FDA 510(k) premarket notification submitted by Kulzer, LLC for the device "iCEM Universal Plus". The FDA issued a decision of Substantially Equivalent on December 19, 2025. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Kulzer, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2025
- Date Received
- December 17, 2025
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type