The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Aadva Zr Disk.
| Device ID | K082740 |
| 510k Number | K082740 |
| Device Name: | GC AADVA ZR DISK |
| Classification | Powder, Porcelain |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-18 |
| Decision Date | 2008-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKLE8781211 | K082740 | 000 |
| EKLE8781231 | K082740 | 000 |
| EKLE8781241 | K082740 | 000 |
| EKLE8781251 | K082740 | 000 |
| EKLE8781141 | K082740 | 000 |
| EKLE8781151 | K082740 | 000 |
| EKLE8781161 | K082740 | 000 |
| EKLE8781171 | K082740 | 000 |
| EKLE8781181 | K082740 | 000 |
| EKLE8781191 | K082740 | 000 |
| EKLE8781201 | K082740 | 000 |
| EKLE8781221 | K082740 | 000 |