Imicryl Dis Malzemeleri Sanayi ve Ticaret A.S.
Konya, TR
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. appears in FDA device records in Konya, TR. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Imicryl Dis Malzemeleri Sanayi ve Ticaret A.S. between 2019 and 2022. The busiest year on record is 2021, with 2. The most recent is 2022, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220077 | IMICRYL Composite, Composite Flow Materials | EBF | Substantially Equivalent | |
| K213609 | NOVA RESIN dual cure, self adhesive resin cement | EMA | Substantially Equivalent | |
| K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) | EMA | Substantially Equivalent | |
| K192913 | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose | KLE | Substantially Equivalent | |
| K192178 | R&D Series Nova Compo N | EBF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005176727 | 3005176727 | IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. | Fetih Mahallesi Mahir Sokak No:5/201 Karatay/Konya, Konya 42030 TR | 2026 | and 31 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHRAbsorber, Saliva, Paper
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- EJHAlloy, Metal, Base
- EJSAlloy, Other Noble Metal
- EFDAmalgamator, Dental, Ac-Powered
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- KXRApplicator, Resin
- IWOApron, Protective
- EJPArticulators
- EJLBur, Dental
- DZSCapsule, Dental, Amalgam
- EMACement, Dental
- NUXCleanser, Denture, Prescription
- EFNCotton, Roll
- NKJCushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
- ELMDenture, Plastic, Teeth
- NSLDentures, Full
- NSKDentures, Partial
- EHJDisk, Abrasive
- PMEExternal Cleaning Solution
- EKMGutta-Percha
- DZPInstrument, Diamond, Dental
- EJKLiner, Cavity, Calcium Hydroxide
- ELWMaterial, Impression
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- EAXMirror, Mouth
- JDZMixer, Cement, For Clinical Use
- EBLPin, Retentive And Splinting, And Accessory Instruments
- EEAPlate, Base, Shellac
- EKNPoint, Paper, Endodontic
- EKQPreparer, Root Canal Endodontic
- NSPRestoration, Porcelain
- NSMRestoration, Resin
- NSNRestoration, Resin, Crown And Bridge
- EBCSealant, Pit And Fissure, And Conditioner
- EKKSpreader, Pulp Canal Filling Material, Endodontic
- KMTTray, Fluoride, Disposable
- EGDWax, Dental, Intraoral
- EMBZinc Oxide Eugenol
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain