The following data is part of a premarket notification filed by Biotem Co., Ltd. with the FDA for Ar_n Sla Type Implant System.
| Device ID | K190641 |
| 510k Number | K190641 |
| Device Name: | AR_N SLA Type Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Biotem Co., Ltd. 422 Sasang-ro, Sasang-gu Busan, KR 46925 |
| Contact | Hong Koo Yeo |
| Correspondent | Joyce Bang-kwun Provision Consulting Group Inc. 3350 Shelby St. Suite 200 Ontario, CA 91764 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-13 |
| Decision Date | 2020-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810112920291 | K190641 | 000 |
| 00810112920130 | K190641 | 000 |
| 00810112920123 | K190641 | 000 |
| 00810112920116 | K190641 | 000 |
| 00810112920109 | K190641 | 000 |
| 00810112920093 | K190641 | 000 |
| 00810112920086 | K190641 | 000 |
| 00810112920079 | K190641 | 000 |
| 00810112920062 | K190641 | 000 |
| 00810112920055 | K190641 | 000 |
| 00810112920048 | K190641 | 000 |
| 00810112920031 | K190641 | 000 |
| 00810112920024 | K190641 | 000 |
| 00810112920017 | K190641 | 000 |
| 00810112920147 | K190641 | 000 |
| 00810112920154 | K190641 | 000 |
| 00810112920284 | K190641 | 000 |
| 00810112920277 | K190641 | 000 |
| 00810112920260 | K190641 | 000 |
| 00810112920253 | K190641 | 000 |
| 00810112920246 | K190641 | 000 |
| 00810112920239 | K190641 | 000 |
| 00810112920222 | K190641 | 000 |
| 00810112920215 | K190641 | 000 |
| 00810112920208 | K190641 | 000 |
| 00810112920192 | K190641 | 000 |
| 00810112920185 | K190641 | 000 |
| 00810112920178 | K190641 | 000 |
| 00810112920161 | K190641 | 000 |
| 00810112920000 | K190641 | 000 |