Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026400121

FEI Number

3026400121

Entity Name

ZIRCON PLUS LIMITED

City/State/Country

Ramat Gan Central, IL

Establishment Address

MENDEL MATITYAHU 7, Suite 1, Ramat Gan Central 528704, IL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ZIRCON PLUS LIMITED (Owner Number: 10087265)

Owner / Operator Contact Address

MENDEL MATITYAHU 7, Suite 1, Ramat Gan, IL-M 528704, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100328

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2025-11-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-11-15
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-11-15
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-11-15
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2023-02-06
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2025-11-15
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2025-11-15
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2025-11-15
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2025-11-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-11-15
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2025-11-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-11-15
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2025-11-15
ELW	Material, Impression	Dental	Class 2	872.3660	2025-11-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-11-15

Official Correspondent

Jill Kalfa

US Agent Details

Jill Kalfa Business: Zeek Logistics Email: jill@zeeklogistics.com Phone: (914) 3364627

Related Public Records

Same Entity

ZIRCON PLUS LIMITED

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
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.).
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.

Similar Registrations

Registration Number	Establishment Name	Location
3010864832	3D DENTAL DESINGS AND DEVELOPMENT	Shaker Heights, OH, US
9613375	COLTENE/WHALEDENT AG	ALTSTAETTEN Sankt Gallen, CH
9616065	MANUFACTURERA DENTAL CONTINENTAL	ZAPOPAN Jalisco, MX
3004096429	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.	NYON Vaud, CH
3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026400121. Last updated year: 2026. Please use registration number 3026400121 when referencing this establishment in official correspondence.