510(k) K190139
K190139 is an FDA 510(k) premarket notification submitted by Bioden Co., Ltd. for the device "Zircos-Com". The FDA issued a decision of Substantially Equivalent on Apr 24, 2020. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Bioden Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 24, 2020
- Date Received
- Jan 29, 2019
- 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)