The following data is part of a premarket notification filed by Juno Dentistry Lp with the FDA for Ufill Bulk Fill Posterior Flowable Composite.
| Device ID | K140512 |
| 510k Number | K140512 |
| Device Name: | UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | JUNO DENTISTRY LP 848-1/2 DERBY AVE Orange, CT 06477 |
| Contact | Roger Mastrony |
| Correspondent | Roger Mastrony JUNO DENTISTRY LP 848-1/2 DERBY AVE Orange, CT 06477 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-28 |
| Decision Date | 2014-07-02 |
| Summary: | summary |