510(k) K213765
K213765 is an FDA 510(k) premarket notification submitted by Prismatik Dentalcraft, Inc. for the device "Glidewell 3DP Denture Base Resin". The FDA issued a decision of Substantially Equivalent on Jun 22, 2022. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Prismatik Dentalcraft, Inc. has 58 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 22, 2022
- Date Received
- Dec 1, 2021
- 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)