The following data is part of a premarket notification filed by Jaintek Co.,ltd with the FDA for Ok Handpiece.
| Device ID | K221814 |
| 510k Number | K221814 |
| Device Name: | OK Handpiece |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | Jaintek Co.,Ltd #302, 419, Byeolmang-ro, Danwon-gu Ansan-si, KR 15605 |
| Contact | Jung Gun Lee |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-06-22 |
| Decision Date | 2022-07-15 |