Keymill— 510(k) K172764
Substantially EquivalentMycone Dental Supply Company, Inc. (Aka Keystone Industries)
FDA 510(k) clearance K172764 for Keymill, Substantially Equivalent on 2018-04-27. Applicant: Mycone Dental Supply Company, Inc. (Aka Keystone Industries). Device class: 2.
Clearance details
- Applicant
- Mycone Dental Supply Company, Inc. (Aka Keystone Industries)
- Product code
- Code EBI
- Device class
- Class 2
- Regulation
- 21 CFR 872.3760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
Recent devices under product code EBI
view allAdverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
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.