510(k) K161353
K161353 is an FDA 510(k) premarket notification submitted by Tokuyama Dental Corporation for the device "ESTELITE BULK FILL Flow". The FDA issued a decision of Substantially Equivalent on Apr 3, 2017. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Tokuyama Dental Corporation has 18 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 3, 2017
- Date Received
- May 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type
- 510(k)