The following data is part of a premarket notification filed by Microware Precision Co., Ltd. with the FDA for Bio-ray A-1 Anchor Screw System.
| Device ID | K182929 |
| 510k Number | K182929 |
| Device Name: | BIO-RAY A-1 Anchor Screw System |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | Microware Precision Co., Ltd. No. 12, Keyuan 2nd Rd., Situn District Taichung, TW 40763 |
| Contact | Harrison Du |
| Correspondent | Harrison Du Microware Precision Co., Ltd. No. 12, Keyuan 2nd Rd., Situn District Taichung, TW 40763 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-22 |
| Decision Date | 2019-11-06 |