Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2515379

FEI Number

2515379

Entity Name

DENTSPLY LLC

City/State/Country

MILFORD, DE, US

Establishment Address

38 WEST CLARKE AVENUE, MILFORD, DE 19963, US

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

K896659

PMA Number

N/A

All Registered Proprietary Names

Universal Tray Adhesive MTML Impression Tray Pack HiTray MTM Clear Aligner Patient Case (contains only impression trays, not aligners) Self-Cure GENIE MAGIC MIX ULTRA HYDR Barricaid Perio Dressing Sporox II Cerec Camera Care Kit Esthet-X Improved, Esthet-X Micro Matrix, TPH3 Flow, Esthet-X Easy Twist TPH Improved, Prisma Composite Polishing Paste Tylok Cement Jeltrate Plus Fluorshield VLC Adaptable Composite Resin Delton PLUS Lucitone Digital Print Lucitone Digital Print for Primeprint NUPRO Virtual Intra Oral Tips Oral Tips Mixing Tips Virtual Mixing Tips Virtual Dispenser Intra Oral Tips Zircon diamond burr set Esthet-X Flow TPH Spectra ST SureFil Restorative Delton Opaque Pit & Fissure Sealant Dentin Desensitizer Agent Drills GATES LARGO Integrity Multi-Cure Sample Aquasil Ultra Cordless digit Power Dispenser digit Syringe Dispenser Aquasil Ulta+ Smart Wetting IMpression Material Tooth Conditioner Gel Reprosil Regisil Tray Adhesive Calibra Esthetic Resin Cement XENO IV Palodent Delton FS+ Aquasil Ultra XLV Hydrosil Regisil Reprosil digit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	1999-04-05
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2008-01-17
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2008-04-16
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2008-04-16
MVL	Cord, Retraction	Unknown	Class U	N/A	2019-03-25
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2008-01-16
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	1977-12-28
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-16
ELW	Material, Impression	Dental	Class 2	872.3660	2003-12-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-17
ELW	Material, Impression	Dental	Class 2	872.3660	2008-04-16
ELW	Material, Impression	Dental	Class 2	872.3660	2008-01-16
EJJ	Alloy, Amalgam	Dental	Class 2	872.3070	2008-03-13
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2008-04-16
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	1996-05-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-03-12
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-03-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-03-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-03-12
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-01-17
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-16
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2015-12-28
ELW	Material, Impression	Dental	Class 2	872.3660	2008-03-31
ELW	Material, Impression	Dental	Class 2	872.3660	2008-03-13
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2008-01-16
EMA	Cement, Dental	Dental	Class 2	872.3275	2018-10-30
EJJ	Alloy, Amalgam	Dental	Class 2	872.3070	2008-01-16
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2009-04-15
ELW	Material, Impression	Dental	Class 2	872.3660	2015-03-12
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2007-11-19
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2007-11-19
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2008-03-06
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2008-03-13
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2019-05-23
ELW	Material, Impression	Dental	Class 2	872.3660	2012-02-07
ELR	Post, Root Canal	Dental	Class 1	872.3810	1984-11-16
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2023-11-03
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2023-11-03
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2023-11-03
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2023-11-03
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2008-03-13
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	1977-12-28
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	1997-01-17
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2000-07-11
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	1995-08-11
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2014-02-06
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-03-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-06-26
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-03-13
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2008-03-06
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2016-06-17
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2008-03-05
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	1996-08-21
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2011-06-07
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	1977-12-15
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2008-03-06
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2019-11-20
NTK	Caries Detector, Laser Light, Transmission	Dental	Class 2	872.1745	2019-11-20
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2008-03-13
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2015-06-18
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	1979-02-20
ELW	Material, Impression	Dental	Class 2	872.3660	2016-03-04
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-16
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2003-10-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-01-17
ELW	Material, Impression	Dental	Class 2	872.3660	2008-03-13
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-16
EFH	Paper, Articulation	Dental	Class 1	872.6140	2003-09-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2024-04-10
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-18
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2008-03-13
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2008-03-06
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2021-10-19
ELW	Material, Impression	Dental	Class 2	872.3660	2008-07-18
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2008-03-13
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2014-02-18

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
K033381	Discus Dental, Inc.	DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL	2004-01-27
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
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.
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
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.).

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3014268398	LLRN PERSONAL CARE (SHENZHEN) CO.,LTD	shenzhen Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2515379. Last updated year: 2026. Please use registration number 2515379 when referencing this establishment in official correspondence.