Cleared Traditional

Calcium Bridge

K153191 · Denali Corporation · Dental
Feb 2016
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K153191 is an FDA 510(k) clearance for the Calcium Bridge, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Denali Corporation (Hanover, US). The FDA issued a Cleared decision on February 26, 2016, 115 days after receiving the submission on November 3, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K153191 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2015
Decision Date February 26, 2016
Days to Decision 115 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690