Cleared Traditional

K153191 - Calcium Bridge

K153191 is an FDA 510(k) clearance for Calcium Bridge, manufactured by Denali Corporation. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K153191 · Denali Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
115d
Days
Class 2
Risk

K153191 is an FDA 510(k) clearance for the Calcium Bridge. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Denali Corporation (Hanover, US). The FDA issued a Cleared decision on February 26, 2016 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Denali Corporation devices

FDA 510(k) Submission Details - K153191

510(k) Number K153191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 127d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 689
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K153191.
everX Posterior
K153127 · GC America, Inc. · May 2016
Pulpdent Solo Flowable Composite with MCP
K153249 · Pulpdent Corporation · Apr 2016
BEAUTIFIL II Gingiva
K151700 · Shofu Dental Corporation · Mar 2016
BEAUTIFIL II Enamel
K151699 · Shofu Dental Corporation · Dec 2015
Admira Fusion x-tra
K151956 · Voco GmbH · Oct 2015
G-Fix
K151541 · GC America, Inc. · Oct 2015