510(k) K180463
K180463 is an FDA 510(k) premarket notification submitted by Greenway Yw, LLC for the device "Apoller Flow Light Cure Flowable Composite". The FDA issued a decision of Substantially Equivalent on Nov 14, 2018. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 14, 2018
- Date Received
- Feb 21, 2018
- Clearance Type
- Abbreviated
- 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)