The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Absolute Dentin 2.
| Device ID | K132115 |
| 510k Number | K132115 |
| Device Name: | ABSOLUTE DENTIN 2 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PARKELL, INC. 300 EXECUTIVE DR. Edgewood, NY 11717 |
| Contact | Robert Burke |
| Correspondent | Robert Burke PARKELL, INC. 300 EXECUTIVE DR. Edgewood, NY 11717 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-09 |
| Decision Date | 2014-06-25 |
| Summary: | summary |