The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Metalprimer Ii.
| Device ID | K972594 |
| 510k Number | K972594 |
| Device Name: | METALPRIMER II |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Joritz |
| Correspondent | Terry L Joritz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-11 |
| Decision Date | 1997-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24548161297346 | K972594 | 000 |