FDA 510(k) Premarket Notification K153476: KATANA AVENCIA Block

Submission Details & Decision

Normalized public record details for 510(k) notification K153476.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K153476

Applicant / Sponsor

Kuraray Noritake Dental, Inc.

Device Name

KATANA AVENCIA Block

Product Code

EBF

Decision Date

2016-08-23

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Traditional

Third Party Flag

Date Received

2015-12-02

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