The following data is part of a premarket notification filed by Parkell with the FDA for Primer-p Adhesive Agent.
| Device ID | K896719 |
| 510k Number | K896719 |
| Device Name: | PRIMER-P ADHESIVE AGENT |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | PARKELL 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Contact | J Gendusa,dds |
| Correspondent | J Gendusa,dds PARKELL 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-29 |
| Decision Date | 1990-02-22 |