Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000243214

FEI Number

1000243214

Entity Name

POLIDENT d.o.o., Dental products industry

City/State/Country

VOLCJA DRAGA Rence-Vogrsko, SI

Establishment Address

VOLCJA DRAGA 42, VOLCJA DRAGA Rence-Vogrsko 5293, SI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Polident d.o.o. (Owner Number: 9021465)

Owner / Operator Contact Address

VOLCJA DRAGA 42, --, VOLCJA DRAGA, SI-201 5293, SI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K926070

PMA Number

N/A

All Registered Proprietary Names

Artificial teeth CROSS LINKED 2 Artificial teeth REF-LINE Artificial teeth ICX-ROYAL PMMA CAD/CAM disc DD poly Y ML PRIMODENT ACRYLIC TEETH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2015-02-11
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2005-08-03

Official Correspondent

Beate Pececnik

US Agent Details

Steven M. Braykovich Business: AXSYS Inc Email: steveb@axsysinc.com Phone: (248) 9268810

Related Public Records

Same Entity

Polident d.o.o.

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
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

Similar Registrations

Registration Number	Establishment Name	Location
3016564992	DENTAC LLC	North Miami, FL, US
3042623520	ZINGO DIGITAL DENTAL LAB LLC	Mount Prospect, IL, US
3010253209	ENTA B.V.	Bergen op Zoom Noord-Brabant, NL
3007740664	Shenzhen Jiahong Dental Technology Co., Ltd	Shenzhen Guangdong, CN
3002727993	GEBDI DENTAL PRODUCTS GMBH	Engen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000243214. Last updated year: 2026. Please use registration number 1000243214 when referencing this establishment in official correspondence.