PREFORMED TEMPLATE FOR TOOTH POSITIONER— 510(k) K891328
Substantially EquivalentAmerican Orthodontics
FDA 510(k) clearance K891328 for PREFORMED TEMPLATE FOR TOOTH POSITIONER, Substantially Equivalent on 1989-03-31. Applicant: American Orthodontics.
Clearance details
- Applicant
- American Orthodontics
- Product code
- 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.