The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Pattern Resin.
| Device ID | K942670 |
| 510k Number | K942670 |
| Device Name: | GC PATTERN RESIN |
| Classification | Crown And Bridge, Temporary, 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-06 |
| Decision Date | 1994-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6583352051 | K942670 | 000 |
| 10386040001038 | K942670 | 000 |
| 10386040001045 | K942670 | 000 |
| 10386040003414 | K942670 | 000 |
| 10386040006682 | K942670 | 000 |
| D6583352011 | K942670 | 000 |
| D6583352021 | K942670 | 000 |
| D6583352031 | K942670 | 000 |
| D6583352041 | K942670 | 000 |
| 10386040000949 | K942670 | 000 |