510(k) K210473
K210473 is an FDA 510(k) premarket notification submitted by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS for the device "Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)". The FDA issued a decision of Substantially Equivalent on Nov 2, 2021. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Imicryl Dis Malzemeleri Sanayi VE Ticaret AS has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 2, 2021
- Date Received
- Feb 17, 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
- 510(k)