Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011532731

FEI Number

3011532731

Entity Name

PERFLEX LTD

City/State/Country

Netanya Central, IL

Establishment Address

4 Hamelacha str. New Ind. Area, Netanya Central 4250539, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Perflex Ltd (Owner Number: 10048177)

Owner / Operator Contact Address

4 Hamelacha str. New Ind. Area, Netanya, IL-NOTA 4250539, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150454

PMA Number

N/A

All Registered Proprietary Names

Flexiclean Thermofix , BDImpress ACRYFREE BIOSENS FLEXINYLON T-Crystal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2015-12-20
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2014-12-14
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2015-06-01
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2015-06-01

Official Correspondent

Mrs. Perla Ben-Simon

US Agent Details

Benzy Arazy Business: Medes USA C/O Matan Arazy Email: Medes@Arazygroup.com Phone: (415) 9921126

Related Public Records

Same Entity

Perflex 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
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19

Similar Registrations

Registration Number	Establishment Name	Location
1314819	Haleon US Holdings LLC	East Durham, NY, US
3014545262	LMA SOLUTIONS INC.	Raleigh, NC, US
1058743	REGENT LABS, INC.	Deerfield Bch, FL, US
3009211643	WEIHAI HUIHAI COMMODITY MANUFACTURE CO., LTD.	Weihai Shandong, CN
1821514	KULZER, LLC	SOUTH BEND, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011532731. Last updated year: 2026. Please use registration number 3011532731 when referencing this establishment in official correspondence.