The following data is part of a premarket notification filed by Micro-nx Co., Ltd. with the FDA for Dental Handpiece, Model Ca160, Ca160l, And Ca500l.
| Device ID | K220577 |
| 510k Number | K220577 |
| Device Name: | Dental Handpiece, Model CA160, CA160L, And CA500L |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | Micro-NX Co., Ltd. 22 Maeyeo-ro 1 Gil Dong-gu, KR 41059 |
| Contact | Sojeong Park |
| Correspondent | Seohee Kwon K-Bio Solutions 201 South 4th Street, Suite 727 San Jose, CA 95112 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-28 |
| Decision Date | 2022-07-29 |