ASD Oral Appliances— 510(k) K163580
Substantially EquivalentAmerican Sleep Dentistry
FDA 510(k) clearance K163580 for ASD Oral Appliances, Substantially Equivalent on 2017-06-08. Applicant: American Sleep Dentistry.
Clearance details
- Applicant
- American Sleep Dentistry
- Product code
- Code LRK
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cedar City, UT, US
Adverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
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.