Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005176727

FEI Number

3005176727

Entity Name

IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.

City/State/Country

Konya, TR

Establishment Address

Fetih Mahallesi Mahir Sokak No:5/201 Karatay/Konya, Konya 42030, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. (Owner Number: 10062241)

Owner / Operator Contact Address

Fetih Mahallesi Mahir Sokak No:5/201 Karatay/Konya, Konya, TR-42 42030, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 DENTAL ALLOY 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZS	Capsule, Dental, Amalgam	Dental	Class 1	872.3110	2021-02-01
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	2021-02-01
NSK	Dentures, Partial	Unknown	Class N	N/A	2022-07-08
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2021-02-01
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2022-07-20
PME	External Cleaning Solution	Dental	Class 2	872.3260	2021-10-15
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2021-01-20
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2022-08-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-08-10
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2022-08-10
EFN	Cotton, Roll	Dental	Class 1	872.6050	2021-02-01
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2022-07-19
EMA	Cement, Dental	Dental	Class 2	872.3275	2021-11-03
NSL	Dentures, Full	Unknown	Class N	N/A	2022-07-08
NUX	Cleanser, Denture, Prescription	Dental	Class 1	872.3520	2021-02-01
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2022-07-08
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2022-07-20
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2021-02-01
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2021-02-01
EFD	Amalgamator, Dental, Ac-Powered	Dental	Class 1	872.3100	2021-02-01
NKJ	Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter	Dental	Class 1	872.3540	2022-01-28
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2021-02-01
EJL	Bur, Dental	Dental	Class 1	872.3240	2021-02-01
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2022-01-25
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-01-02
KXR	Applicator, Resin	Dental	Class 1	872.3140	2022-07-20
EKM	Gutta-Percha	Dental	Class 1	872.3850	2021-02-01
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2021-01-29
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2021-02-01
ELW	Material, Impression	Dental	Class 2	872.3660	2022-02-14
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2021-02-01
NSM	Restoration, Resin	Unknown	Class N	N/A	2022-07-20
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2021-01-29

Official Correspondent

Husamettin SONMEZ

US Agent Details

ABDUL BILAL GUNDUZ Email: support@imicryl.com Phone: (347) 3355196

Related Public Records

Same Entity

IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.

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
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19
K071131	3M Espe AG Dental Products	UNO	2007-07-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
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.).

Similar Registrations

Registration Number	Establishment Name	Location
2020703	WYKLE RESEARCH, INC.	CARSON CITY, NV, US
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
2024312	Kerr Corporation	ORANGE, CA, US
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3008912871	SAMTRADE SUPPLIES INC.	TORONTO Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005176727. Last updated year: 2026. Please use registration number 3005176727 when referencing this establishment in official correspondence.