SURFACE COAT— 510(k) K063228
Substantially EquivalentKuraray America, Inc.
FDA 510(k) clearance K063228 for SURFACE COAT, Substantially Equivalent on 2006-12-08. Applicant: Kuraray America, Inc.. Device class: 2.
Clearance details
- Applicant
- Kuraray America, Inc.
- Product code
- Code EBD
- Device class
- Class 2
- Regulation
- 21 CFR 872.3310
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
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