510(k) K241056
K241056 is an FDA 510(k) premarket notification submitted by Sincera Technology (Changchun) Co., Ltd. for the device "Light Cure Adhesive". The FDA issued a decision of Substantially Equivalent on July 16, 2024. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Sincera Technology (Changchun) Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2024
- Date Received
- April 18, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agent, Tooth Bonding, Resin
- Device Class
- Class II
- Regulation Number
- 872.3200
- Review Panel
- DE
- Submission Type