Registered with FDA
LLD Care d.o.o.
Zagreb, Croatia. Lists 25 dental device types with FDA across 1 registered establishment.
- Device types listed
- 25
- Brands and models
- 35
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Croatia
Devices listed with FDA
What LLD Care d.o.o. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Lister | Aluminum OxideAquasil UltraDENMAT PREC JARTray Adhesive | 2026 |
| Dental CementEMA · Class 2 | Dental cements | Lister | Fuji IFuji IIFujicem EvolveImplant Cement | 2026 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | EsthetMaterial, Tooth shade, ResinSurefil | 2026 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | Agent, Tooth BondingCavity ConditionerMicroprime | 2026 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Contact MatrixInstruments, Dental, Palodent | 2026 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | Material, Tooth shade, Resin | 2026 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | Integrity | 2026 |
| Roll CottonEFN · Class 1 | — | Lister | Retraction Cap | 2026 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | X-Ray Holder | 2026 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | Glitter, Paste Cups | 2025 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | T-Loc | 2025 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Syringe Tips | 2025 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Retractor | 2025 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | Powder, Porcelain, Celtra and Cerec Blocks | 2026 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Lister | Periowise | 2025 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Lister | PFI Instrument | 2025 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | Enamel, Prophy Paste | 2025 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Lister | — | 2025 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Lister | RC-Prep | 2025 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Lister | Implant Scaler | 2025 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | Elevator Perio | 2025 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Lister | Premier Matrix Refill | 2025 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Lister | Pro Clean Stain Cleaner | 2025 |
| AirbrushKOJ · Class 2 | — | Lister | Microetcher | 2026 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Biogreen applicators | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
LLD Care d.o.o. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dentsply Intl., Inc. (4), GC America Inc. (3), Danville Engineering, Inc. (2), 3M Company Espe Dental Products (1), Dentsply Sirona, Inc. (1), Dentply International, Inc. (1), Danville Materials, LLC (1), Philips Medical Systems International BV (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 13 Jun 2022 | K221695 | 3M Filtek Supreme Flowable Restorative | 3M Company Espe Dental Products | EBF Resin Tooth Shade Material |
| 11 Jul 2019 | K182854 | GC FujiCEM 2 (Improved) | GC America Inc. | EMA Dental Cement |
| 28 Sep 2018 | K181476 | Prime&Bond active Universal Adhesive | Dentsply Sirona, Inc. | KLE Resin Tooth Bonding Agent |
| 4 Mar 2016 | K152861 | Aquasil Ultra + Smart Wetting Impression Material | Dentply International, Inc. | ELW Impression Material |
| 22 Feb 2013 | K123615 | IRIS - HIGH STRENGTH GLASS CERAMIC | Dentsply Intl., Inc. | EIH Porcelain Powder |
| 16 Sep 2009 | K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | Danville Materials, LLC | ELW Impression Material |
| 25 Mar 2004 | K040053 | PRECISION VPS IMPRESSION MATERIAL | Philips Medical Systems International BV | ELW Impression Material |
| 26 Jan 2004 | K033309 | PREMIER IMPLANT CEMENT, MODEL 3001450 | Premier Dental Products Company | EMA Dental Cement |
| 24 Jan 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 13 Jan 1999 | K984387 | R-30 AESTHETIC RESTORATIVE | Dentsply Intl., Inc. | EBF Resin Tooth Shade Material |
| 9 Feb 1998 | K973221 | COMPOSITE 168 RESTORATIVE SYSTEM | Dentsply Intl., Inc. | EBF Resin Tooth Shade Material |
| 3 Oct 1995 | K953504 | MICROPRIME | Danville Engineering, Inc. | KLE Resin Tooth Bonding Agent |
| 27 Sep 1995 | K953166 | FUJI BOND LC | GC America Inc. | KLE Resin Tooth Bonding Agent |
| 20 Jan 1995 | K946100 | FUJI DUET | GC America Inc. | EMA Dental Cement |
| 30 Oct 1991 | K913884 | FUJI II LC | G-C Intl. Corp. | EMA Dental Cement |
| 20 Nov 1990 | K902836 | MICROETCHER | Danville Engineering, Inc. | KOJ Airbrush |
| 7 Aug 1980 | K801142 | PALODENT MATRICES & BITINE RINGS | Alvin Meyer, D.D.S. | DZN Dental Hand Instruments |
| 31 Aug 1978 | K781151 | REPROSIL | Dentsply Intl., Inc. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LLD CARE D.O.O.FDA reg. 3042244574 | Zagreb Zagreb, Grad, Croatia | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094252). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.