Cleared Traditional

K173124 - PEEK Biosolution

K173124 is an FDA 510(k) clearance for PEEK Biosolution, manufactured by Merz Dental GmbH. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K173124 · Merz Dental GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
80d
Days
Class 2
Risk

K173124 is an FDA 510(k) clearance for the PEEK Biosolution. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Merz Dental GmbH (Lutjenburg, DE). The FDA issued a Cleared decision on December 18, 2017 after a review of 80 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Merz Dental GmbH devices

FDA 510(k) Submission Details - K173124

510(k) Number K173124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date December 18, 2017
Days to Decision 80 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
47d faster than avg
Panel avg: 127d · This submission: 80d
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 685
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K173124.
OMNICHROMA
K173275 · Tokuyama Dental Corporation · Feb 2018
Trilor Disks, Blocks and Arches
K173643 · Bioloren S.R.L. · Feb 2018
Ecosite Bulk Fill
K171772 · Dmg USA, Inc. · Jan 2018
BEAUTIFIL Flow Plus X
K172530 · Shofu Dental Corporation · Dec 2017
Renamel Microfill
K172707 · Cosmedent, Inc. · Dec 2017
Registrado Scan
K171815 · Voco GmbH · Nov 2017