510(k) K173643
K173643 is an FDA 510(k) premarket notification submitted by Bioloren S.R.L. for the device "Trilor Disks, Blocks and Arches". The FDA issued a decision of Substantially Equivalent on Feb 24, 2018. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Bioloren S.R.L. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 24, 2018
- Date Received
- Nov 27, 2017
- Clearance Type
- Special
- 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)