SMARTCOAT 2.5% NAF VARNISH— 510(k) K131376
Substantially EquivalentElevate Oral Care
FDA 510(k) clearance K131376 for SMARTCOAT 2.5% NAF VARNISH, Substantially Equivalent on 2013-08-27. Applicant: Elevate Oral Care. Device class: 2.
Clearance details
- Applicant
- Elevate Oral Care
- Product code
- Code LBH
- Device class
- Class 2
- Regulation
- 21 CFR 872.3260
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Palm Beach, FL, US
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