Cleared Traditional

K153490 - DD medical polymers

K153490 is an FDA 510(k) clearance for DD medical polymers, manufactured by Dental Direkt GmbH. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K153490 · Dental Direkt GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
161d
Days
Class 2
Risk

K153490 is an FDA 510(k) clearance for the DD medical polymers. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Dental Direkt GmbH (Spenge, DE). The FDA issued a Cleared decision on May 13, 2016 after a review of 161 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Dental Direkt GmbH devices

FDA 510(k) Submission Details - K153490

510(k) Number K153490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2015
Decision Date May 13, 2016
Days to Decision 161 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
34d slower than avg
Panel avg: 127d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 113
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K153490.
Harvest Dental Polymer Blocks
K180578 · Harvest Dental Products, LLC · Dec 2018
Resin for Temporary Crown & Bridge
K180657 · Dentis Co., Ltd. · Dec 2018
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
K180562 · Zirkonzahn GmbH · Jun 2018
TelioCAD Multi
K153753 · Ivoclar Vivadent, Inc. · Apr 2016
MSN-006
K141562 · GC America, Inc. · Sep 2014
TUFF-TEMP 2.0
K120784 · Pulpdent Corporation · Jun 2012