The following data is part of a premarket notification filed by Park Dental Research Corporation with the FDA for Juell 3d Volo Base.
| Device ID | K181220 |
| 510k Number | K181220 |
| Device Name: | Juell 3D Volo Base |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Park Dental Research Corporation 2401 N. Commerce Street Suite E Ardmore, OK 73401 |
| Contact | Ronald A Bulard |
| Correspondent | Angela Blackwell Blackwell Device Consulting P.O. BOX 718 Gresham, OR 97030 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-10-12 |
| Summary: | summary |