Manufacturer registered with FDA
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
Konya, Türkiye. Lists 33 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 33
- Brands and models
- 50
- 510(k) clearances
- 52019–2022
- Markets registered in
- 428 registrations outside the US
- Establishments
- 1Türkiye
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Imicryl Dis Malzemeleri Sanayi VE Ticaret AS as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 5 clearances | 2019–2022 | Below |
| Serbia | ALIMS | Manufacturer | IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. | 26 | 2022–2025 | Pure Global AI |
| Egypt | EDA | Manufacturer | IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S., | 1 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Imicryl Dis Malzemeleri Sanayi VE Ticaret AS currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, SwarpeNova Compo HF, Othocompo, Luxera, MaritzaNova Compo N, Nova Compo SF, Nova Compo O, Nova Compo CNova Compomer (Classic and Rainbow)Nova Resin Cement | 2020 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, SwarpeNova Compo HF, Othocompo, Luxera, MaritzaNova Resin Cement | 2022 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Nova Aqua GIL, Nova Aqua GIFNova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus, Nova Glass GL)Nova Glass II F, Nova Glass II LC, Fissured II NovaNova Resin Cement | 2021 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | DENTAL DIAMOND | 2021 |
| Amalgam Dental CapsuleDZS · Class 1 | — | Lister | AMALGAMAX | 2021 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | DENTAL MIRROR | 2021 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | IMIBASE | 2021 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | IMICRYL Interdental Brush, ROLENE Prophylaxis Brushes, ROLENE Bonding Brushes, PANORA Plaque Covers | 2022 |
| Shellac Base PlateEEA · Class 1 | — | Maker | IMIBASEIMIBASE ECO | 2021 |
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Lister | DENTAL AMALGAMATOR | 2021 |
| Roll CottonEFN · Class 1 | — | Lister | DENTAL COTTON ROLL | 2021 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | IMIWAX CEREMONYNOVAWAX | 2021 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Lister | ROLENE | 2021 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Lister | DENTAL ALLOY | 2021 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, SwarpeNova Compo HF, Othocompo, Luxera, Maritza | 2022 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | DENTAL BUR | 2021 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Lister | ARTICULATORS | 2021 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | IMIPRINT, IMISHINE, IMIPOMZA, Panora 200, Royalry | 2021 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Lister | DENTAL ALLOY | 2021 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Calciplus LC, Calciplus RL, Calciplus, Imical, Biofactor MTA, Therra, Cavitimi | 2022 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | DENTAL GUTTA | 2021 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | DENTAL POINT PAPER | 2021 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | Prosimi, E.D.T.A Solution, Endosolve-HP | 2022 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | IMIDENT LUXPAMA | 2021 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | IMICRYL Impression MaterialsNICETYPE SilREFLECTSPIRIAS | 2022 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | ZINO-EG Zinc Oxide Eugenol Cement | 2021 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | DENTAL ABSORBER, SALIVA, PAPER | 2021 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose | 2021 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | IMITRAY, POLIMO Fluoride Trays | 2021 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Dispensing Gun, Glass Ionomer Capsule Gun, Compomer Capsule Gun | 2022 |
| Over the Counter Wax Impregnated Cotton Denture Pad CushionNKJ · Class 1 | — | Maker | Spanch | 2022 |
| Prescription Denture CleanserNUX · Class 1 | — | Lister | IMIPOMZA | 2021 |
| External Cleaning SolutionPME · Class 2 | — | Maker | CERAXIDIN-C, Vayfic, PAMA Solution, Imisemme, Traysemme | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Imicryl Dis Malzemeleri Sanayi VE Ticaret AS as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Aug 2022 | K220077 | IMICRYL Composite, Composite Flow Materials | EBF Resin Tooth Shade Material |
| 9 Aug 2022 | K213609 | NOVA RESIN dual cure, self adhesive resin cement | EMA Dental Cement |
| 2 Nov 2021 | K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) | EMA Dental Cement |
| 19 Jan 2021 | K192913 | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose | KLE Resin Tooth Bonding Agent |
| 20 Dec 2019 | K192178 | R&D Series Nova Compo N | EBF Resin Tooth Shade Material |
Also lists devices cleared under other names
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS 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: Imicryl Dis Malzemeleri San. VE Tic. A.S. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Feb 2022 | K213890 | IMICRYL Impression Materials | Imicryl Dis Malzemeleri San. VE Tic. A.S. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.FDA reg. 3005176727 | Konya, Türkiye | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062241). 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.