D.SIGN 30— 510(k) K010381
Substantially EquivalentIvoclar North America, Inc.
FDA 510(k) clearance K010381 for D.SIGN 30, Substantially Equivalent on 2001-03-06. Applicant: Ivoclar North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Ivoclar North America, Inc.
- Product code
- Code EJH
- Device class
- Class 2
- Regulation
- 21 CFR 872.3710
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Amherst, NY, US
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