The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Et Smartfit Abutment.
| Device ID | K123627 |
| 510k Number | K123627 |
| Device Name: | ET SMARTFIT ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-23 |
| Decision Date | 2013-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814913026145 | K123627 | 000 |
| 00814913026138 | K123627 | 000 |
| 00814913026121 | K123627 | 000 |
| 00814913026114 | K123627 | 000 |
| 00814913023519 | K123627 | 000 |
| 00814913023502 | K123627 | 000 |
| 00814913023496 | K123627 | 000 |
| 00814913023489 | K123627 | 000 |