The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Pour Acrylic.
| Device ID | K161330 |
| 510k Number | K161330 |
| Device Name: | Pour Acrylic |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-12 |
| Decision Date | 2016-10-06 |