Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681199

FEI Number

3003999430

Entity Name

DEGUDENT GMBH

City/State/Country

HANAU Hesse, DE

Establishment Address

RODENBACHER CHAUSSEE 4, HANAU Hesse 63457, DE

Establishment Type(s)

Manufacture Medical 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

K202629

PMA Number

N/A

All Registered Proprietary Names

Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit Shaded PMMA VIPI BLOCK PMMA Disks Multilayer PMMA 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 Option Duceragold Kiss Cerec Essentials Materials Starter Kit Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit Duceram Kiss Porcelain Duceram Plus Porcelain LFC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2019-05-23
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2017-12-22
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2017-10-25
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-08-16
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2017-02-27
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2020-01-06
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2003-10-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-12-18
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2008-01-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-12-18
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2013-03-08
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2008-01-28
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2008-01-28
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
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-05-09
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2024-05-09
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-12-16
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-04-07
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2006-09-20
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-09-05
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2008-02-28
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-03-10

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
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K915626	Ivoclar North America, Inc.	EZ GOLD	1992-02-25
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18

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

Similar Registrations

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2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681199. Last updated year: 2026. Please use registration number 9681199 when referencing this establishment in official correspondence.