The following data is part of a premarket notification filed by Juell Dental with the FDA for Juell Hard Cure.
| Device ID | K111177 |
| 510k Number | K111177 |
| Device Name: | JUELL HARD CURE |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | JUELL DENTAL 2401 N COMMERCE Ardmore, OK 73401 |
| Contact | Angela Blackwell |
| Correspondent | Angela Blackwell JUELL DENTAL 2401 N COMMERCE Ardmore, OK 73401 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-27 |
| Decision Date | 2011-09-12 |
| Summary: | summary |