510(k) K201683
K201683 is an FDA 510(k) premarket notification submitted by Huge Dental Material Co., Ltd. for the device "PMMA Block". The FDA issued a decision of Substantially Equivalent on November 3, 2020. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Huge Dental Material Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2020
- Date Received
- June 22, 2020
- 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