The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Nature-cryl Hi Plus.
| Device ID | K051358 |
| 510k Number | K051358 |
| Device Name: | NATURE-CRYL HI PLUS |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-24 |
| Decision Date | 2005-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10386040008198 | K051358 | 000 |
| 10386040008068 | K051358 | 000 |
| 10386040008051 | K051358 | 000 |
| 10386040008044 | K051358 | 000 |
| 10386040008037 | K051358 | 000 |
| 10386040008020 | K051358 | 000 |
| 10386040008013 | K051358 | 000 |
| 10386040008006 | K051358 | 000 |
| 10386040007993 | K051358 | 000 |
| 10386040007986 | K051358 | 000 |
| 10386040008075 | K051358 | 000 |
| 10386040008082 | K051358 | 000 |
| 10386040008099 | K051358 | 000 |
| 10386040008181 | K051358 | 000 |
| 10386040008174 | K051358 | 000 |
| 10386040008167 | K051358 | 000 |
| 10386040008150 | K051358 | 000 |
| 10386040008143 | K051358 | 000 |
| 10386040008136 | K051358 | 000 |
| 10386040008129 | K051358 | 000 |
| 10386040008112 | K051358 | 000 |
| 10386040008105 | K051358 | 000 |
| 10386040007979 | K051358 | 000 |