CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK— 510(k) K111975
Substantially EquivalentKuraray Medical, Inc.
FDA 510(k) clearance K111975 for CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK, Substantially Equivalent on 2011-10-14. Applicant: Kuraray Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Kuraray Medical, Inc.
- Product code
- Code KLE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chiyoda-Ku, Tokyo, JP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.