510(k) K223706
K223706 is an FDA 510(k) premarket notification submitted by Huliang(Shanghai) Bio-Tech Co., Ltd. for the device "PMMA BLOCK". The FDA issued a decision of Substantially Equivalent on May 12, 2023. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 2023
- Date Received
- December 12, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown And Bridge, Temporary, Resin
- Device Class
- Class II
- Regulation Number
- 872.3770
- Review Panel
- DE
- Submission Type