510(k) K191591
K191591 is an FDA 510(k) premarket notification submitted by Enlighten Materials Co., Ltd. for the device "BB Base 3D printing resin for denture base". The FDA issued a decision of Substantially Equivalent on Aug 18, 2020. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Enlighten Materials Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 18, 2020
- Date Received
- Jun 14, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Denture, Relining, Repairing, Rebasing
- Device Class
- Class II
- Regulation Number
- 872.3760
- Review Panel
- DE
- Submission Type
- 510(k)