K091660
Substantially EquivalentCUSTOM COMFORT NIGHTGUARD VERSION 2
- Applicant
- Den Tek Oral Care, Inc.
- Product code
- OBR
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Washington, DC, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.