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 |