FDA 510(k) and CE Status of the Materials We Use

A 510(k) is the premarket submission a manufacturer files with the U.S. FDA before marketing a medical device; the CE mark is affixed by the manufacturer after assessment by a notified body under EU rules. Every number below links to the original record or document so you can verify it.

First page of FDA 510(k) letter K171585 to Dentalmax for LUXEN Zr, LUXEN Smile
FDA K171585 – Dentalmax, Luxen
CE 0123 marking printed on the Ivoclar IPS e.max ZirCAD instructions for use
CE 0123 – Ivoclar, IPS e.max ZirCAD Prime
15Material lines with records
22FDA records
8CE-marked lines
13 Oct 2026Last checked

Note: these are the manufacturers’ records for their materials. Khai Nguyen is not registered with the FDA as an establishment; restorations we make to a dentist’s prescription are custom-made devices and do not carry the CE mark. The lab holds its own ISO 13485:2016 certification.

Cercon ht

FDA × 1
Version 510(k) number Applicant, decision date
Cercon ht
CERCON HT		 K112152 Dentsply International, Inc., 9 Nov 2011

Material page: Cercon ht

DD Bio

FDA × 4CE 0482
Version 510(k) number Applicant, decision date
DD Bio Z, DD Bio ZX²
DD Bio Z, DD Bio ZX(square), DD BioZX(square) color		 K142987 Dental Direkt of Amerika UG (Haftungsbeschraenkt), 11 Feb 2015
DD cubeX²
DD cubeX2		 K150196 Dental Direkt GmbH, 26 Mar 2015
DD cube ONE
DD cubeX2 HS		 K170885 Dental Direkt GmbH, 1 Aug 2017
DD cube ONE ML
DD cube ONE ML		 K183569 Dental Direkt GmbH, 14 Feb 2019
Version CE marking Manufacturer's document
DD cube ONE, DD cube ONE ML
Dental Direkt GmbH		 CE 0482
Class IIa		 DD cube ONE IFU (Rev.11, 2021)

Material page: DD Bio

DMAX

FDA × 1
Version 510(k) number Applicant, decision date
Multi M
Multi M Series		 K250826 Dmax Co., Ltd., 12 Jun 2025

Material page: DMAX

Ceramill Zolid / Zi

FDA × 4
Version 510(k) number Applicant, decision date
Zolid HT+ White, Zolid HT+ Preshades, Zolid Gen-X, Zolid Bion, Zolid DRS
Ceramill Zolid HT+ white		 K171876 Amann Girrbach AG, 20 Sep 2017
Zolid FX Multilayer
Ceramill Zolid FX		 K152383 Emergo Europe Consulting, 21 Sep 2015
Zolid Lunaris
Zolid Lunaris		 K260918 Amann Girrbach AG, 29 Jun 2026
Ceramill Zi
CERAMILL ZI		 K063511 Amann Girrbach America, Inc., 2 Feb 2007

Material page: Ceramill Zolid / Zi

IPS e.max CAD

FDA × 1
Version 510(k) number Applicant, decision date
IPS e.max CAD
IPS E.MAX CAD/IPS E.MAX ZIRCAD		 K051705 Ivoclar Vivadent, Inc., 14 Oct 2005

Material page: IPS e.max CAD

IPS e.max Press

FDA × 1
Version 510(k) number Applicant, decision date
IPS e.max Press Multi
IPS E.MAX PRESS MULTI		 K120134 Ivoclar Vivadent, AG, 25 Jun 2012

Material page: IPS e.max Press

GC Initial LiSi Press

FDA × 1CE 2797
Version 510(k) number Applicant, decision date
GC Initial LiSi Press
Initial LiSi Press		 K153136 GC America, Inc., 30 Jun 2016
Version CE marking Manufacturer's document
GC Initial LiSi Press
GC Corporation		 CE 2797
Regulation (EU) 2017/745 (MDR)		 GC Initial LiSi Press IFU (10/2025)

Material page: GC Initial LiSi Press

Shofu Vintage LD

FDA × 1
Version 510(k) number Applicant, decision date
Vintage LD Press
VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN		 K032416 Shofu Dental Corp., 5 Feb 2004

Material page: Shofu Vintage LD

Amber Mill

FDA × 2CE 2195
Version 510(k) number Applicant, decision date
Amber Mill
Amber Mill Series and Amber Press Series		 K160102 Hass Corp., 14 Jul 2016
Amber Mill Q, Amber Mill Direct
Amber Mill Q Series & Amber Mill Direct Series		 K202952 Hass Corp., 26 Aug 2021
Version CE marking Manufacturer's document
Amber Mill, Amber Mill Q, Amber Mill Direct
HASS Corp.		 CE 2195 HASS Amber Mill IFU (HS-IFU-707 Rev.05, 2026)

Material page: Amber Mill

Luxen

FDA × 2CE 2292
Version 510(k) number Applicant, decision date
Luxen 1200+600 Multi, Luxen 1100 Multi
LUXEN Zr, LUXEN Smile		 K171585 Dentalmax Co., Ltd., 31 Oct 2018
Luxen 5G Smile
LUXEN 5G		 K241151 Dentalmax Co., Ltd., 30 Sep 2024
Version CE marking Manufacturer's document
Luxen 1200+600 Multi, Luxen 1100 Multi, Luxen 5G Smile
Dentalmax Co., Ltd.		 CE 2292 Luxen IFU DM-DMF-100 v5.6 (2025)

Material page: Luxen

Sagemax NexxZr

FDA × 1CE 0123
Version 510(k) number Applicant, decision date
NexxZr T, NexxZr+
NEXXZR(TM)T AND NEXXZR(TM)S		 K130991 Sagemax Bioceramics, Inc., 10 Feb 2014
Version CE marking Manufacturer's document
NexxZr T, NexxZr+, NexxZr T Multi, NexxZr+ Multi
Sagemax Bioceramics, Inc.		 CE 0123
Regulation (EU) 2017/745 (MDR)		 Sagemax Zirconia Portfolio flyer (EN/MDR/2024-03/Rev.2)

Material page: Sagemax NexxZr

Everest

FDA × 1
Version 510(k) number Applicant, decision date
Everest Multilayer PT, Everest Multilayer AT, Razor 1300
Razor, Everest, U&C Liquid		 K191902 U&C International Co., Ltd., 11 Oct 2019

Material page: Everest

Copran Zri

FDA × 1CE 0483
Version 510(k) number Applicant, decision date
Copran Zri white, Copran Zri light, Copran Zri medium, Copran Zri intense
Copran Zri		 K232952 Whitepeaks Dental Solutions GmbH, 24 Jun 2024
Version CE marking Manufacturer's document
Copran Zri white, Copran Zri light, Copran Zri medium, Copran Zri intense
Whitepeaks Dental Solutions GmbH		 CE 0483
Class IIa, Regulation (EU) 2017/745 (MDR)		 Whitepeaks EU declaration of conformity 731 Copran Rev. 2 (released 2026-01-12)

Material page: Copran Zri

How to verify

  1. 1. Click a 510(k) numberThe link opens the record in the FDA 510(k) database.
  2. 2. Open the manufacturer's CE documentThe CE number is printed in the manufacturer's instructions for use or declaration of conformity.
  3. 3. Search EUDAMEDLook the device up by name in the EU medical device database.