FDA Registration
Active
🇹🇷 Türkiye
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
Reg #: 3005176727
·
FEI: 3005176727
·
Expires 2026
Products
41
Proprietary Names
51
Establishment Types
2
Classifications
41
Registration Details
- Registration Name
- IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
- Registration Number
- 3005176727
- FEI Number
- 3005176727
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Fetih Mahallesi Mahir Sokak No:5/201 Karatay/Konya
- City
- Konya
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K192913
Owner / Operator
- Firm Name
- IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
- Operator Number
- 10062241
- Address
- Fetih Mahallesi Mahir Sokak No:5/201 Karatay/Konya
- City
- Konya
- State
- TR-42
- Postal Code
- 42030
- Country
- TR
- Correspondent
- Husamettin SONMEZ
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Capsule, Dental, Amalgam | DZS | Class 1 | Dental | No | 2021-02-01 |
| Alloy, Other Noble Metal | EJS | Class 2 | Dental | No | 2021-02-01 |
| Dentures, Partial | NSK | Class N | Unknown | No | 2022-07-08 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2021-02-01 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 2022-07-20 |
| External Cleaning Solution | PME | Class 2 | Dental | No | 2021-10-15 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2021-01-20 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2022-08-10 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2022-08-10 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2022-08-10 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2021-02-01 |
| Restoration, Porcelain | NSP | Class N | Unknown | No | 2022-07-19 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2021-11-03 |
| Dentures, Full | NSL | Class N | Unknown | No | 2022-07-08 |
| Cleanser, Denture, Prescription | NUX | Class 1 | Dental | No | 2021-02-01 |
| Restoration, Resin, Crown And Bridge | NSN | Class N | Unknown | No | 2022-07-08 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2022-07-20 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2021-02-01 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2021-02-01 |
| Amalgamator, Dental, Ac-Powered | EFD | Class 1 | Dental | No | 2021-02-01 |
| Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter | NKJ | Class 1 | Dental | No | 2022-01-28 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2021-02-01 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2021-02-01 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2022-01-25 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2022-07-20 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2021-02-01 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2021-01-29 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2021-02-01 |
| Material, Impression | ELW | Class 2 | Dental | No | 2022-02-14 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2021-02-01 |
| Restoration, Resin | NSM | Class N | Unknown | No | 2022-07-20 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2021-01-29 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2021-02-01 |
| Plate, Base, Shellac | EEA | Class 1 | Dental | No | 2021-02-01 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2021-02-01 |
| Articulators | EJP | Class 1 | Dental | No | 2021-01-29 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2021-10-15 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2021-02-01 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 2022-07-20 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2021-02-01 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2024-06-03 |
Proprietary Names
AMALGAMAX
DENTAL ALLOY
O-80 Orthodontic Acrylic
SC Self Cure Acrylic
ROLENE
Prosimi, E.D.T.A Solution, Endosolve-HP
CERAXIDIN-C, Vayfic, PAMA Solution, Imisemme, Traysemme
R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
Nova Compo HF, Othocompo, Luxera, Maritza
Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe
DENTAL COTTON ROLL
Ceramica
Nova 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 Nova
Nova Aqua GIL, Nova Aqua GIF
IQ-15 Heat Cure Acrylic
IMIPOMZA
IMIBOND-F, IMIBOND-P, IMIBOND AQUA-P, IMIDENT
Calciplus LC, Calciplus RL, Calciplus, Imical, Biofactor MTA, Therra, Cavitimi
IMITRAY, POLIMO Fluoride Trays
DENTAL AMALGAMATOR
Spanch
DENTAL POINT PAPER
DENTAL BUR
Mixing Bowls
Nova Compo N, Nova Compo SF, Nova Compo O, Nova Compo C
Nova Compomer (Classic and Rainbow)
Dispensing Gun, Glass Ionomer Capsule Gun, Compomer Capsule Gun
DENTAL GUTTA
PAMA
IMIDENT LUX
IMIPRINT, IMISHINE, IMIPOMZA, Panora 200, Royalry
SPIRIAS
IMICRYL Impression Materials
NICETY
PE Sil
REFLECT
DENTAL MIRROR
Fissured Nova, Fissured Nova Plus, Bisotic, Polimo Fluoride Varnish, Polimo Fluoride Gel
ZINO-EG Zinc Oxide Eugenol Cement
NOVAWAX
IMIWAX CEREMONY
IMIBASE ECO
IMIBASE
DENTAL DIAMOND
ARTICULATORS
Clean & Clean Bibs and Cover
Nova Resin Cement
IMICRYL Interdental Brush, ROLENE Prophylaxis Brushes, ROLENE Bonding Brushes, PANORA Plaque Covers
DENTAL ABSORBER, SALIVA, PAPER
ROLENE SALIVA EJECTOR
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device