K904128
Substantially EquivalentPERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
- Applicant
- American Orthodontics
- Product code
- KMY
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sheboygan, WI, US
Adverse events under product code KMY
product code KMY- Injury
- 1,457
- Total
- 1,457
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.