OPAL BOND FLOW— 510(k) K100301
Substantially EquivalentUltradent Products, Inc.
FDA 510(k) clearance K100301 for OPAL BOND FLOW, Substantially Equivalent on 2010-04-29. Applicant: Ultradent Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Ultradent Products, Inc.
- Product code
- Code DYH
- Device class
- Class 2
- Regulation
- 21 CFR 872.3750
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Jordan, UT, US
Recent devices under product code DYH
view allMore clearances from Ultradent Products, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.