The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Glidewell 3dp Denture Base Resin.
| Device ID | K213765 |
| 510k Number | K213765 |
| Device Name: | Glidewell 3DP Denture Base Resin |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine, CA 92612 |
| Contact | Jiahe Li |
| Correspondent | Jiahe Li Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine, CA 92612 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-01 |
| Decision Date | 2022-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745701164GBD00030 | K213765 | 000 |
| D745701164GBD00020 | K213765 | 000 |
| D745701164GBD00010 | K213765 | 000 |