The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for Hiossen Prosthetic System.
| Device ID | K140507 |
| 510k Number | K140507 |
| Device Name: | HIOSSEN PROSTHETIC SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | OSSTEM IMPLANT CO., LTD. 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Contact | Patrick Lim |
| Correspondent | Patrick Lim OSSTEM IMPLANT CO., LTD. 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2014-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800000963327 | K140507 | 000 |
| 08800000925448 | K140507 | 000 |
| 08800000925431 | K140507 | 000 |
| 08800000925424 | K140507 | 000 |
| 08800000925417 | K140507 | 000 |
| 08800000925400 | K140507 | 000 |
| 08800000925394 | K140507 | 000 |
| 08800000925387 | K140507 | 000 |
| 00810019241796 | K140507 | 000 |
| 00810019241789 | K140507 | 000 |
| 00810019241772 | K140507 | 000 |
| 00810019241765 | K140507 | 000 |
| 08809892359041 | K140507 | 000 |
| 08809892359027 | K140507 | 000 |
| 08809892359003 | K140507 | 000 |
| 08800000925455 | K140507 | 000 |
| 08800000925462 | K140507 | 000 |
| 08800000925608 | K140507 | 000 |
| 08800000925592 | K140507 | 000 |
| 08800000925585 | K140507 | 000 |
| 08800000925578 | K140507 | 000 |
| 08800000925561 | K140507 | 000 |
| 08800000925554 | K140507 | 000 |
| 08800000925547 | K140507 | 000 |
| 08800000925530 | K140507 | 000 |
| 08800000925523 | K140507 | 000 |
| 08800000925516 | K140507 | 000 |
| 08800000925509 | K140507 | 000 |
| 08800000925493 | K140507 | 000 |
| 08800000925486 | K140507 | 000 |
| 08800000925479 | K140507 | 000 |
| 08809892358983 | K140507 | 000 |