The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Mi Paste Plus.
| Device ID | K070854 |
| 510k Number | K070854 |
| Device Name: | GC MI PASTE PLUS |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| 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 | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-28 |
| Decision Date | 2007-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20386040008621 | K070854 | 000 |
| 20386040008614 | K070854 | 000 |
| 20386040008607 | K070854 | 000 |
| 20386040008591 | K070854 | 000 |