The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Etiii Sa Fixture System (o3.2mm).
| Device ID | K153332 |
| 510k Number | K153332 |
| Device Name: | ETIII SA Fixture System (O3.2mm) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | HIOSSEN INC. 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Contact | Patrick Lim |
| Correspondent | David Kim HIOSSEN INC. 85 BEN FAIRLESS DR. 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 | 2015-11-19 |
| Decision Date | 2016-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814913024486 | K153332 | 000 |
| 00814913020549 | K153332 | 000 |
| 00814913020532 | K153332 | 000 |
| 00814913020525 | K153332 | 000 |
| 00814913020518 | K153332 | 000 |
| 00814913028859 | K153332 | 000 |
| 00814913028842 | K153332 | 000 |
| 00814913028835 | K153332 | 000 |
| 00814913028828 | K153332 | 000 |
| 00814913028811 | K153332 | 000 |
| 00814913028804 | K153332 | 000 |
| 00814913028798 | K153332 | 000 |
| 00814913028781 | K153332 | 000 |
| 00814913028774 | K153332 | 000 |
| 00814913020556 | K153332 | 000 |
| 00814913024349 | K153332 | 000 |
| 00814913024479 | K153332 | 000 |
| 00814913024462 | K153332 | 000 |
| 00814913024455 | K153332 | 000 |
| 00814913024448 | K153332 | 000 |
| 00814913024431 | K153332 | 000 |
| 00814913024424 | K153332 | 000 |
| 00814913024417 | K153332 | 000 |
| 00814913024400 | K153332 | 000 |
| 00814913024394 | K153332 | 000 |
| 00814913024387 | K153332 | 000 |
| 00814913024370 | K153332 | 000 |
| 00814913024363 | K153332 | 000 |
| 00814913024356 | K153332 | 000 |
| 00814913028767 | K153332 | 000 |