BIO-RAY A-1 Anchor Screw System— 510(k) K182929
Substantially EquivalentMicroware Precision Co., Ltd.
FDA 510(k) clearance K182929 for BIO-RAY A-1 Anchor Screw System, Substantially Equivalent on 2019-11-06. Applicant: Microware Precision Co., Ltd..
Clearance details
- Applicant
- Microware Precision Co., Ltd.
- Product code
- Code OAT
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung City, TW
Adverse events under product code OAT
product code OAT- Injury
- 355
- Total
- 355
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.