The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Coe Comfort.
| Device ID | K070698 |
| 510k Number | K070698 |
| Device Name: | COE COMFORT |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-13 |
| Decision Date | 2007-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10386040006873 | K070698 | 000 |
| D6583410021 | K070698 | 000 |
| D6583410041 | K070698 | 000 |
| D6583410911 | K070698 | 000 |
| D6583410921 | K070698 | 000 |
| 20386040000335 | K070698 | 000 |
| 10386040000840 | K070698 | 000 |
| 10386040003667 | K070698 | 000 |
| 10386040006859 | K070698 | 000 |
| D6583410012 | K070698 | 000 |