The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Fuji Duet.
| Device ID | K946100 |
| 510k Number | K946100 |
| Device Name: | FUJI DUET |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-14 |
| Decision Date | 1995-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10386040009164 | K946100 | 000 |
| D6584310122 | K946100 | 000 |
| D6584310912 | K946100 | 000 |
| D6584311011 | K946100 | 000 |
| 24548161283080 | K946100 | 000 |
| 00386040008832 | K946100 | 000 |
| 00386040008849 | K946100 | 000 |
| 20386040009130 | K946100 | 000 |
| 20386040009147 | K946100 | 000 |
| 20386040009154 | K946100 | 000 |
| D6584310112 | K946100 | 000 |