CLEARFIL SA CEMENT— 510(k) K081583
Substantially EquivalentKuraray Medical, Inc.
FDA 510(k) clearance K081583 for CLEARFIL SA CEMENT, Substantially Equivalent on 2008-07-28. Applicant: Kuraray Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Kuraray Medical, Inc.
- Product code
- Code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code EMA
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- K111975 — CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
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- K092281 — CLEARFIL MAJESTY POSTERIOR PLT
Data sourced from openFDA. This site is unofficial and independent of the FDA.