The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Xlc-100 Capsule.
| Device ID | K061535 |
| 510k Number | K061535 |
| Device Name: | GC XLC-100 CAPSULE |
| Classification | Cement, Dental |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Joritz-lyons |
| Correspondent | Terry L Joritz-lyons 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 | 2006-06-02 |
| Decision Date | 2006-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386040009419 | K061535 | 000 |
| 04548161330230 | K061535 | 000 |
| 04548161330223 | K061535 | 000 |
| 04548161293504 | K061535 | 000 |
| 04548161293498 | K061535 | 000 |
| 04548161291135 | K061535 | 000 |
| 04548161282409 | K061535 | 000 |
| 04548161282331 | K061535 | 000 |
| 04548161282256 | K061535 | 000 |