Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030452

FEI Number

3003943714

Entity Name

VERTEX-DENTAL B.V.

City/State/Country

Soesterberg Utrecht, NL

Establishment Address

Centurionbaan 190, Soesterberg Utrecht 3769 AV, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Vertex-Dental B.V. (Owner Number: 8030452)

Owner / Operator Contact Address

Centurionbaan 190, Soesterberg, NL-UT 3769AV, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191497

PMA Number

N/A

All Registered Proprietary Names

NextDent Ortho Rigid E-Guard NextDent Ortho Clear Dental LT Clear Ceramill Ortho Rigid Ceramill Ortho Flex NextDent Ortho Flex Implacryl Rapid Simplified Castavaria Castapress Self-Curing NextDent Jet Base NextDent Jet Teeth NextDent Base NextDent Denture NextDent Base Thermodent (Confidential) NextDent Tray NextDent Ortho IBT E-IDB Ceramill Tray Ceramill Ortho IBT Vertex Trayplast Saremco Print Crowntec NextDent Try-In Ceramill Try-In NextDent Ortho Flex NextDent Denture 3D+ Ceramill Denture 3D+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2016-02-11
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2011-05-11
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2011-05-11
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2024-09-06
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2024-09-06
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2024-09-06
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2023-11-16
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2017-07-05
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2013-03-25
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2015-06-15
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2022-04-01
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2022-04-01
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-04-01
EEA	Plate, Base, Shellac	Dental	Class 1	872.6200	2018-07-30
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2022-11-03
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2022-11-03
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2019-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

Mindy McCann Business: Qserve Group US Inc. Email: usagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

Vertex-Dental B.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3015143007	SMYLIO	Fremont, CA, US
3007513373	E. TEC SA DE C.V.	Tijuana Baja California, MX
3028340833	EH Labs CZ s.r.o.	Dvur Kralove nad Labem Hradec Kralove, CZ
3019793783	Aceso Dental Laboratory Company Limited	An Phuoc Ward Dong Nai, VN
3008910197	Park Dental Research Corp	Ardmore, OK, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030452. Last updated year: 2026. Please use registration number 8030452 when referencing this establishment in official correspondence.