ENAMEL PRO— 510(k) K062166
Substantially EquivalentPremier Dental Products Co.
FDA 510(k) clearance K062166 for ENAMEL PRO, Substantially Equivalent on 2006-11-21. Applicant: Premier Dental Products Co.. Device class: 1.
Clearance details
- Applicant
- Premier Dental Products Co.
- Product code
- Code EJR
- Device class
- Class 1
- Regulation
- 21 CFR 872.6030
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth Meeting, PA, US
Recent devices under product code EJR
view allMore clearances from Premier Dental Products Co.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.