KeyPrint KeySplint Hard— 510(k) K203000
Substantially EquivalentMycone Dental Supply Co. Inc. (Dba Keystone Industries)
FDA 510(k) clearance K203000 for KeyPrint KeySplint Hard, Substantially Equivalent on 2021-04-09. Applicant: Mycone Dental Supply Co. Inc. (Dba Keystone Industries).
Clearance details
- Applicant
- Mycone Dental Supply Co. Inc. (Dba Keystone Industries)
- Product code
- Code MQC
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
Adverse events under product code MQC
product code MQC- Injury
- 377
- Total
- 377
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.