The following data is part of a premarket notification filed by The Hygenic Corp. with the FDA for Novus Bonding Agent.
| Device ID | K900301 |
| 510k Number | K900301 |
| Device Name: | NOVUS BONDING AGENT |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
| Contact | Meyer |
| Correspondent | Meyer THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-22 |
| Decision Date | 1990-05-15 |