510(k) K242749
K242749 is an FDA 510(k) premarket notification submitted by Rizhao Huge Biomaterials Company, Ltd. for the device "TopCEM Ceramic Primer Ceramic Coupling Agent". The FDA issued a decision of Substantially Equivalent on November 8, 2024. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Rizhao Huge Biomaterials Company, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 2024
- Date Received
- September 12, 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