DeviceClearance

BLUEPHASE STYLE— 510(k) K110756

Substantially Equivalent

Ivoclar Vivadent, Inc.

FDA 510(k) clearance K110756 for BLUEPHASE STYLE, Substantially Equivalent on 2011-08-29. Applicant: Ivoclar Vivadent, Inc.. Device class: 2.

Clearance details

Applicant
Ivoclar Vivadent, Inc.
Product code
Code EBZ
Device class
Class 2
Regulation
21 CFR 872.6070
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Amherst, NY, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K110756

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110756.

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