DENTSPLY SIRONA INC

FDA Device Registration & Listing · York, PA, US · Registration 3004884150

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
3004884150
FEI Number
3004884150
Entity Name
DENTSPLY SIRONA INC
City/State/Country
York, PA, US
Establishment Address
221 W Philadelphia St Ste 60w, York, PA 17401, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
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
K150909
PMA Number
N/A

All Registered Proprietary Names

Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit Midwest E mini OSSIX VOLUMAX OSSIX™ Bone Ossix Agile Ossix Breeze OSSIX Plus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-11-14
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2022-11-14
EIH Powder, Porcelain Dental Class 2 872.6660 2017-12-22
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2024-02-01
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2018-12-18
ELW Material, Impression Dental Class 2 872.3660 2018-12-18
EHD Unit, X-Ray, Extraoral With Timer Dental Class 2 872.1800 2018-12-18
EJH Alloy, Metal, Base Dental Class 2 872.3710 2006-09-20
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2020-07-16
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-05-01
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2025-05-01
NXC Aligner, Sequential Dental Class 2 872.5470 2023-10-27
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2018-12-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-12-18
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2018-12-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-12-18
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2017-12-12
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2006-02-28
EAZ Light, Operating, Dental Dental Class 1 872.4630 1987-07-02
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2018-12-18
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2020-01-06
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2022-07-11
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2001-10-23
EIH Powder, Porcelain Dental Class 2 872.6660 2018-12-18
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2018-12-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-12-18
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2019-08-06
NXC Aligner, Sequential Dental Class 2 872.5470 2021-02-12
EIH Powder, Porcelain Dental Class 2 872.6660 2021-04-07
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-12-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-12-18
EFA Handpiece, Belt And/Or Gear Driven, Dental Dental Class 1 872.4200 2018-12-18
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2022-09-21
EIA Unit, Operative Dental Dental Class 1 872.6640 2018-12-18
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2023-10-27
MQC Mouthguard, Prescription Unknown Class U N/A 2023-10-27
NTK Caries Detector, Laser Light, Transmission Dental Class 2 872.1745 2025-09-11
NBL Laser, Fluorescence Caries Detection Dental Class 2 872.1745 2025-09-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-12-18
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2022-09-21
DYJ Retainer, Screw Expansion, Orthodontic Dental Class 1 872.5410 1997-01-28
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2005-03-01
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-12-18
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2018-12-18
PNN Orthodontic Software Dental Class 2 872.5470 2019-03-25
EIA Unit, Operative Dental Dental Class 1 872.6640 2018-12-18
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2018-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18
K143656 H.C. Starck Ceramics GmbH StarCeram® Z-Nature, StarCeram® Z-Smile 2015-07-09
K243921 Foshan Coxo Medical Instrument Co., Ltd. LED Curing Lights (DB686 HALO) 2025-04-11
K033201 Apoza Enterprise Co., Ltd. LA500 BLUE LIGHT 2003-12-02
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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

Similar Registrations

Registration Number Establishment Name Location
3013578168 DDS CARIBBEAN CORP Guaynabo, PR, US
3030690317 TRATE LLC Tamarac, FL, US
3011587077 JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD. Changzhou Jiangsu, CN
3012121192 DENTAL EVOLUTIONS, INC Beverly Hills, CA, US
3031529635 TRATE UAB Kaunas Kauno Apskritis, LT
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004884150. Last updated year: 2026. Please use registration number 3004884150 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.