Cleared Traditional

K182780 - XP Composite

K182780 is an FDA 510(k) clearance for XP Composite, manufactured by S&C Polymer Silicon- Und Composite Spezialitaeten GmbH. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K182780 · S&C Polymer Silicon- Und Composite Spezialitaeten GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
275d
Days
Class 2
Risk

K182780 is an FDA 510(k) clearance for the XP Composite. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by S&C Polymer Silicon- Und Composite Spezialitaeten GmbH (Elmshorn, DE). The FDA issued a Cleared decision on July 3, 2019 after a review of 275 days - an extended review 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: 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 S&C Polymer Silicon- Und Composite Spezialitaeten GmbH devices

FDA 510(k) Submission Details - K182780

510(k) Number K182780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2018
Decision Date July 03, 2019
Days to Decision 275 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
148d slower than avg
Panel avg: 127d · This submission: 275d
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 645
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K182780.
Opus Bulk Fill APS, Opus Bulk Fill Flow APS
K190758 · Dentscare Ltda · Sep 2019
Novidia Bulk Fill Flow Composite
K182714 · Nobio , Ltd. · Jul 2019
Novidia Flowable Composite
K182580 · Nobio , Ltd. · Jul 2019
BRILLIANT EverGlow Flow
K190597 · Coltene/Whaledent AG · Jun 2019
CLEARFIL MAJESTY IC
K182430 · Kuraray Noritake Dental, Inc. · May 2019
LC GLOSSFILL XR
K182778 · S&C Polymer Silicon- Und Composite Spezialitaeten GmbH · Apr 2019