Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614977

FEI Number

3003719498

Entity Name

SIRONA DENTAL SYSTEMS GMBH

City/State/Country

BENSHEIM Hesse, DE

Establishment Address

FABRIKSTRASSE 31, BENSHEIM Hesse D-64625, DE

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

Expiration Date (Year)

2026

510(k) Number

K011061

PMA Number

N/A

All Registered Proprietary Names

Shorty Handpiece & Motor, Midwest Handpiece, Contra Angle Heads Straight Attachments Rhino Handpiece Midwest RDH Midwest Shorty Single Speed Air Motor Rhino XP Midwest Rhino XP Midwest Shorty Two Speed Air Motor Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit Tube Extension

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2008-02-18
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2018-12-18
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2018-12-04
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2008-03-06
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2018-12-18
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2006-02-28
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2022-07-11
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
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2026-02-12
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2026-02-12
LQY	Locator, Root Apex	Unknown	Class U	N/A	2026-02-12
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
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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-12-18
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	1997-01-17
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2018-12-18
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2008-02-18
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2022-07-11
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2023-10-27
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	1987-07-02
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2018-12-18
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2025-11-20
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2008-02-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-12-18
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2018-12-18
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2023-10-27
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2019-03-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-03-25
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2019-08-06
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
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2008-02-18
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2020-01-06
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
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2018-12-18
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2018-12-18
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2001-10-23
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2018-12-18
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2006-09-20
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
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2020-07-16
EFA	Handpiece, Belt And/Or Gear Driven, Dental	Dental	Class 1	872.4200	2018-12-18
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2017-12-22
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2024-02-01
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-12-18
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	1992-07-09
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2023-10-27
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2023-10-27
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2023-10-27
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2026-02-10
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2018-12-18
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2018-12-18
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2023-12-12
ELW	Material, Impression	Dental	Class 2	872.3660	2018-12-18
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2008-01-21

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
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614977. Last updated year: 2026. Please use registration number 9614977 when referencing this establishment in official correspondence.