The following data is part of a premarket notification filed by Kuraray America, Inc. with the FDA for Alloy Primer.
| Device ID | K974089 |
| 510k Number | K974089 |
| Device Name: | ALLOY PRIMER |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KURARAY AMERICA, INC. 200 PARK AVE. New York, NY 10166 -3098 |
| Contact | Keji Fujita |
| Correspondent | Keji Fujita KURARAY AMERICA, INC. 200 PARK AVE. New York, NY 10166 -3098 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-29 |
| Decision Date | 1997-12-17 |