The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Unifast Trad.
| Device ID | K984365 |
| 510k Number | K984365 |
| Device Name: | GC UNIFAST TRAD |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-07 |
| Decision Date | 1999-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6583392922 | K984365 | 000 |
| 20386040001196 | K984365 | 000 |
| 20386040001189 | K984365 | 000 |
| 10386040001175 | K984365 | 000 |
| 10386040001168 | K984365 | 000 |
| 10386040001151 | K984365 | 000 |
| 20386040001141 | K984365 | 000 |
| 20386040000991 | K984365 | 000 |
| 20386040000984 | K984365 | 000 |
| 20386040000977 | K984365 | 000 |
| 20386040000960 | K984365 | 000 |
| 20386040006696 | K984365 | 000 |
| D6583391022 | K984365 | 000 |
| D6583392912 | K984365 | 000 |
| D6583391251 | K984365 | 000 |
| D6583391241 | K984365 | 000 |
| D6583391231 | K984365 | 000 |
| D6583391152 | K984365 | 000 |
| D6583391142 | K984365 | 000 |
| D6583391132 | K984365 | 000 |
| D6583391052 | K984365 | 000 |
| D6583391042 | K984365 | 000 |
| D6583391032 | K984365 | 000 |
| 20386040000953 | K984365 | 000 |