Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042244574

FEI Number

3042244574

Entity Name

LLD CARE D.O.O.

City/State/Country

Zagreb Zagreb, Grad, HR

Establishment Address

Mrksina 11c, Zagreb Zagreb, Grad 10020, HR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

LLD Care d.o.o. (Owner Number: 10094252)

Owner / Operator Contact Address

Mrksina 11c, Zagreb, HR-21 10020, HR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pro Clean Stain Cleaner Premier Matrix Refill Latex-Free Tourniquet Glitter, Paste Cups Material, Tooth shade, Resin Periowise Hemodent RC-Prep PFI Instrument Enamel, Prophy Paste Implant Cement Syringe Tips Irrigation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JER	Cleaner, Denture, Mechanical	Dental	Class 1	872.3530	2025-11-20
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2025-11-20
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2025-11-20
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2026-04-08
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2025-11-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-04-08
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2026-04-08
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2025-11-20
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-11-24
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2025-11-20
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2025-11-20
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2025-11-20
EMA	Cement, Dental	Dental	Class 2	872.3275	2026-02-06
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2025-11-20
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2026-04-24

Official Correspondent

Jelena Miladinovic Drazetic

US Agent Details

Michael Antar Email: maamds@gmail.com Phone: (917) 5896715

Related Public Records

Same Entity

LLD Care d.o.o.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

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-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
2210679	UNETTE CORPORATION	Randolph, NJ, US
1483306	ASTRON DENTAL CORPORATION	Lake Zurich, IL, US
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
3017498782	BRIGHT SUPPLY INC	Canoga Park, CA, US
3043654467	CHANGSHA GOMECY ELECTRONICS CO., LTD.	Changsha Hunan, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042244574. Last updated year: 2026. Please use registration number 3042244574 when referencing this establishment in official correspondence.