The following data is part of a premarket notification filed by Hrs Co., Ltd. with the FDA for Sildent.
| Device ID | K132869 |
| 510k Number | K132869 |
| Device Name: | SILDENT |
| Classification | Material, Impression |
| Applicant | HRS CO., LTD. 216-5 BLOCK 6 CHOOPAL INDUSTRIAL COMPLEX 394-1 CHOOPAL-RI Pyongtaek, KR 451-805 |
| Contact | Jae-hyeon Choi |
| Correspondent | Jae-hyeon Choi HRS CO., LTD. 216-5 BLOCK 6 CHOOPAL INDUSTRIAL COMPLEX 394-1 CHOOPAL-RI Pyongtaek, KR 451-805 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-13 |
| Decision Date | 2014-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809746990048 | K132869 | 000 |
| 08809746990031 | K132869 | 000 |
| 08809746990024 | K132869 | 000 |
| 18809746990014 | K132869 | 000 |