The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Multi Angled Abutment System.
| Device ID | K132067 |
| 510k Number | K132067 |
| Device Name: | MULTI ANGLED ABUTMENT SYSTEM |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-03 |
| Decision Date | 2013-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800000925370 | K132067 | 000 |
| 00814913028750 | K132067 | 000 |
| 00814913028743 | K132067 | 000 |
| 00814913028736 | K132067 | 000 |
| 00814913028729 | K132067 | 000 |
| 00814913028712 | K132067 | 000 |
| 00814913028705 | K132067 | 000 |
| 00814913028699 | K132067 | 000 |
| 00814913028682 | K132067 | 000 |
| 00814913028675 | K132067 | 000 |
| 00814913028668 | K132067 | 000 |
| 00814913028651 | K132067 | 000 |
| 08800000925240 | K132067 | 000 |
| 08800000925257 | K132067 | 000 |
| 08800000925363 | K132067 | 000 |
| 08800000925356 | K132067 | 000 |
| 08800000925349 | K132067 | 000 |
| 08800000925332 | K132067 | 000 |
| 08800000925325 | K132067 | 000 |
| 08800000925318 | K132067 | 000 |
| 08800000925301 | K132067 | 000 |
| 08800000925295 | K132067 | 000 |
| 08800000925288 | K132067 | 000 |
| 08800000925271 | K132067 | 000 |
| 08800000925264 | K132067 | 000 |
| 00814913028644 | K132067 | 000 |