Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010638

FEI Number

3004724816

Entity Name

DENTSPLY DETREY GmbH

City/State/Country

KONSTANZ Baden-Wurttemberg, DE

Establishment Address

DETREY STRASSE 1, KONSTANZ Baden-Wurttemberg 78467, 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

K040144

PMA Number

N/A

All Registered Proprietary Names

Tylok Cement

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-16
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2018-11-28
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2015-12-28
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2018-10-22
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2025-02-20
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2016-06-17
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	1977-12-28
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2006-09-29
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-16
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	1992-08-05
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2008-01-28
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-03-12

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
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

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.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

Similar Registrations

Registration Number	Establishment Name	Location
8030419	SUN MEDICAL CO., LTD.	Moriyama Shiga, JP
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3035693034	Solventum Germany GmbH	Kist Bavaria, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3003775534	GC EUROPE N.V.	LEUVEN Vlaams Brabant, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010638. Last updated year: 2026. Please use registration number 8010638 when referencing this establishment in official correspondence.