The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Parkell Universal Adhesive.
| Device ID | K172176 |
| 510k Number | K172176 |
| Device Name: | Parkell Universal Adhesive |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 |
| Contact | David Mott |
| Correspondent | David Mott Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-19 |
| Decision Date | 2017-11-21 |
| Summary: | summary |