DENTSPLY IH BV

FDA Device Registration & Listing · Sevenum Limburg, NL · Registration 3011824442

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011824442
FEI Number
3011824442
Entity Name
DENTSPLY IH BV
City/State/Country
Sevenum Limburg, NL
Establishment Address
Piri Reisweg 23, Sevenum Limburg 5975 RZ, NL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
DENTSPLY SIRONA INC (Owner Number: 2511302)
Owner / Operator Contact Address
221 WEST PHILADELPHIA ST., SUITE 60W, York, PA 17401, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LFC Cercon Abutments Ankylos Cercon Balance Option Cerec Essentials Materials Starter Kit Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit Tube Extension Contra-angle Dental Abutment/Implant Duceram Kiss Porcelain Duceram Plus Porcelain XiVe TG Ankylos Temporary Abutment Balance Washtray Sterilization Container Implant Universal Body Stain Universal Stain Celtra Ceram Universal Incisal Stain Dentsply Sirona Universal Overglaze CELTRA Duo Dentsply Sirona Universal Incisal Stain Dentsply Sirona Universal Body Stain Universal Overglaze-High Flu Dentsply Sirona Universal Stain & Overglaze Kit Dentsply Sirona Universal Stain Dentsply Sirona Universal Overglaze-High Flu Universal Overglaze TPH Spectra ST Adaptable Composite Resin

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EIH Powder, Porcelain Dental Class 2 872.6660 2008-01-28
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-12-14
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-12-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-12-07
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2014-01-27
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2008-03-28
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2018-10-22
EIH Powder, Porcelain Dental Class 2 872.6660 2017-02-27
EJT Alloy, Gold-Based Noble Metal Dental Class 2 872.3060 2003-10-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2018-11-28
EKD Instrument, Cutting, Operative Dental Class 1 872.4565 2001-10-23
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-01-26
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2025-02-05
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2020-12-16
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2022-07-13
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2008-01-21
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2008-01-16
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-12-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-12-07
JEY Plate, Bone Dental Class 2 872.4760 2008-01-22
EIH Powder, Porcelain Dental Class 2 872.6660 2013-03-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-11-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
LQY Locator, Root Apex Unknown Class U N/A 2024-07-25
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2024-07-25
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-11-15
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2008-01-16
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
EFS Unit, Oral Irrigation Dental Class 1 872.6510 1992-07-09
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2006-09-29
KMW Handpiece, Rotary Bone Cutting Dental Class 2 872.4120 2017-11-02
EKQ Preparer, Root Canal Endodontic Dental Class 1 872.4565 1977-12-28
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2022-03-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-12-16
EIH Powder, Porcelain Dental Class 2 872.6660 2008-01-28
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2008-11-24
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-07-28
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2008-02-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 1992-08-05
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2025-01-23
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-01-23
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-03-25
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2017-08-30
EIH Powder, Porcelain Dental Class 2 872.6660 2021-03-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-11-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-03-12
EIH Powder, Porcelain Dental Class 2 872.6660 2024-09-05
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2016-12-12
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2011-12-16
EIH Powder, Porcelain Dental Class 2 872.6660 2016-08-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2017-06-26
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-03-23
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2023-03-23
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2009-04-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-21
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-11-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
EME Punch, Biopsy, Surgical Dental Class 1 872.4565 2016-12-12
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
EIH Powder, Porcelain Dental Class 2 872.6660 2024-12-16
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
EIH Powder, Porcelain Dental Class 2 872.6660 2008-02-28
DZN Instruments, Dental Hand Dental Class 1 872.4565 2002-03-18
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2025-07-21
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2001-10-23
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2016-06-17
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-04-10
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2022-11-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-11-15
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2008-03-12
EIH Powder, Porcelain Dental Class 2 872.6660 2008-01-28
EJH Alloy, Metal, Base Dental Class 2 872.3710 2006-09-20
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-04-19
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2012-11-19
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2008-11-24
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2010-03-23
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2010-03-23
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-12-16
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2016-12-12
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2020-12-16
KXR Applicator, Resin Dental Class 1 872.3140 1996-03-19

Official Correspondent

No official correspondent registered.

US Agent Details

Dan Eagar Business: DENTSPLY SIRONA INC Email: dan.eagar@dentsplysirona.com Phone: (704) 4926977

Related Public Records

Same Entity

DENTSPLY SIRONA INC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9612618 DEGUDENT GMBH Rosbach V.D.H. Hesse, DE
3003756493 DENTSPLY INDUSTRIA E COMERCIO LTDA PIRASSUNUNGA Sao Paulo, BR
3001226627 RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) ST. EGREVE Isere, FR
3003136642 OraMetrix GmbH Berlin Brandenburg, DE
3000303964 DENTSPLY DENTAL (TIANJIN) CO., LTD. TEDA Tianjin, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K143656 H.C. Starck Ceramics GmbH StarCeram® Z-Nature, StarCeram® Z-Smile 2015-07-09
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18
K081806 Idi Biomedical, LLC IDI IMPLANT SYSTEM 2008-11-07
K120793 Z-Systems AG Z-LOOK3 EVO SLM 2012-12-21
K130140 Intra-Lock International INTRA-LOCK OP DENTAL IMPLANT 2013-08-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011824442. Last updated year: 2026. Please use registration number 3011824442 when referencing this establishment in official correspondence.
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