The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Fuji Ortho Lc.
| Device ID | K981461 |
| 510k Number | K981461 |
| Device Name: | GC FUJI ORTHO LC |
| Classification | Adhesive, Bracket And Tooth Conditioner, 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 | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-23 |
| Decision Date | 1998-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6584230081 | K981461 | 000 |
| 00386040009808 | K981461 | 000 |
| 20386040009796 | K981461 | 000 |
| 20386040009697 | K981461 | 000 |
| 20386040009680 | K981461 | 000 |
| 00386040008658 | K981461 | 000 |
| 14548161072601 | K981461 | 000 |
| 24548161283240 | K981461 | 000 |
| 24548161283035 | K981461 | 000 |