510(k) K162856
K162856 is an FDA 510(k) premarket notification submitted by Bonart Co., Ltd. for the device "Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)". The FDA issued a decision of Substantially Equivalent on July 18, 2017. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Bonart Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2017
- Date Received
- October 12, 2016
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type