SURFACE COAT— 510(k) K063228

Substantially Equivalent

Kuraray 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
Download summary PDFView on FDA.gov ↗

Recent devices under product code EBD

view all

More clearances from Kuraray America, Inc.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.