510(k) K240112
K240112 is an FDA 510(k) premarket notification submitted by Sincera Technology (Changchun) Co., Ltd. for the device "Light Cure Composite". The FDA issued a decision of Substantially Equivalent on March 15, 2024. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Sincera Technology (Changchun) Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2024
- Date Received
- January 16, 2024
- 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