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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 128d · 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 Consultant

Dental Direkt GmbH (Former Dental Direkt of Amerika Ug)
VERA BUESCHER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBG Crown And Bridge, Temporary, Resin

All 172
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K153490.
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
K180562 · Zirkonzahn GmbH · Jun 2018
Fixtemp C&B
K171729 · Dreve Dentamid GmbH · Dec 2017
PuRE PMMA Disc
K172281 · Quest Dental USA Corp. · Oct 2017
Vericore Gradient Temporary Disc
K152443 · Whip Mix Corporation · May 2016
TelioCAD Multi
K153753 · Ivoclar Vivadent, Inc. · Apr 2016
DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
K152215 · Dentalplus GmbH · Jan 2016