Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015189878

FEI Number

3015189878

Entity Name

NOBIO LTD.

City/State/Country

Kadima Central, IL

Establishment Address

8 Hamatechet St., Kadima Central 6092000, IL

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Nobio Ltd. (Owner Number: 10079375)

Owner / Operator Contact Address

8 Hamatechet, Kadima, IL-M 6092000, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201010

PMA Number

N/A

All Registered Proprietary Names

Infinix Universal bond Infinix Bulk Fill Flow Composite Infinix Universal Composite Infinix Flowable Composite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2020-12-03
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-12-03

Official Correspondent

Shlomo Nachmani

US Agent Details

SHOSHANA FRIEDMAN Business: ProMedoss, Inc. Email: S.FRIEDMAN@promedoss.com Phone: (980) 3081636

Related Public Records

Same Entity

Nobio Ltd.

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
3027584973	F & A LABORATORIO FARMACEUTICO LTDA	Sao Paulo-SP, BR
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015189878. Last updated year: 2026. Please use registration number 3015189878 when referencing this establishment in official correspondence.