510(k) K214118
K214118 is an FDA 510(k) premarket notification submitted by Sdi Limited for the device "Riva Cem Automix". The FDA issued a decision of Substantially Equivalent on August 30, 2022. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Sdi Limited has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2022
- Date Received
- December 30, 2021
- 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