The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Reline Ii.
| Device ID | K153253 |
| 510k Number | K153253 |
| Device Name: | GC Reline II |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | GC AMERICA, INC. 3737 W. 127TH ST. Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC AMERICA, INC. 3737 W. 127TH ST. Alsip, IL 60803 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-10 |
| Decision Date | 2016-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14548161321457 | K153253 | 000 |
| 14548161321358 | K153253 | 000 |
| 14548161321365 | K153253 | 000 |
| 14548161321372 | K153253 | 000 |
| 14548161321389 | K153253 | 000 |
| 14548161321396 | K153253 | 000 |
| 14548161321402 | K153253 | 000 |
| 14548161321419 | K153253 | 000 |
| 14548161321426 | K153253 | 000 |
| 14548161321433 | K153253 | 000 |
| 14548161321440 | K153253 | 000 |
| 14548161321341 | K153253 | 000 |