ENAMELAST— 510(k) K132109
Substantially EquivalentUltradent Products Inc. / Oratech, LLC
FDA 510(k) clearance K132109 for ENAMELAST, Substantially Equivalent on 2013-11-01. Applicant: Ultradent Products Inc. / Oratech, LLC.
Clearance details
- Applicant
- Ultradent Products Inc. / Oratech, LLC
- Product code
- Code LBH
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.