The following data is part of a premarket notification filed by Bio-systems Research with the FDA for Permagen Universal Bonding Resin.
| Device ID | K933745 |
| 510k Number | K933745 |
| Device Name: | PERMAGEN UNIVERSAL BONDING RESIN |
| Classification | Material, Impression Tray, Resin |
| Applicant | BIO-SYSTEMS RESEARCH 2057 SUMMIT DR. Lake Oswego, OR 97034 |
| Contact | Arthur J Saffir |
| Correspondent | Arthur J Saffir BIO-SYSTEMS RESEARCH 2057 SUMMIT DR. Lake Oswego, OR 97034 |
| Product Code | EBH |
| CFR Regulation Number | 872.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-03 |
| Decision Date | 1994-01-26 |