510(k) K232978
K232978 is an FDA 510(k) premarket notification submitted by Sino-Dentex Co., Ltd. for the device "DX. Bond V Dental Bonding Adhesive". The FDA issued a decision of Substantially Equivalent on September 22, 2023. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 2023
- Date Received
- September 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Agent, Tooth Bonding, Resin
- Device Class
- Class II
- Regulation Number
- 872.3200
- Review Panel
- DE
- Submission Type