The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Et Ii Bio-sa Fixture System.
| Device ID | K112532 |
| 510k Number | K112532 |
| Device Name: | ET II BIO-SA FIXTURE SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | HIOSSEN INC. 85 BEN FAIRLESS DRIVE Fairless Hills, PA 19030 |
| Contact | Patrick Lim |
| Correspondent | Patrick Lim HIOSSEN INC. 85 BEN FAIRLESS DRIVE Fairless Hills, PA 19030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-31 |
| Decision Date | 2012-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814913020228 | K112532 | 000 |
| 00814913020099 | K112532 | 000 |
| 00814913020082 | K112532 | 000 |
| 00814913020075 | K112532 | 000 |
| 00814913020068 | K112532 | 000 |
| 00814913020051 | K112532 | 000 |
| 00814913020044 | K112532 | 000 |
| 00814913020037 | K112532 | 000 |
| 00814913020020 | K112532 | 000 |
| 00814913020013 | K112532 | 000 |
| 00814913020105 | K112532 | 000 |
| 00814913020112 | K112532 | 000 |
| 00814913020129 | K112532 | 000 |
| 00814913020211 | K112532 | 000 |
| 00814913020204 | K112532 | 000 |
| 00814913020198 | K112532 | 000 |
| 00814913020181 | K112532 | 000 |
| 00814913020174 | K112532 | 000 |
| 00814913020167 | K112532 | 000 |
| 00814913020150 | K112532 | 000 |
| 00814913020143 | K112532 | 000 |
| 00814913020136 | K112532 | 000 |
| 00814913020006 | K112532 | 000 |