Kulzer SRL

FDA Device Registration & Listing · Sacalaz-Judet Timis, RO · Registration 3011203516

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011203516
FEI Number
3011203516
Entity Name
Kulzer SRL
City/State/Country
Sacalaz-Judet Timis, RO
Establishment Address
Claderia C3, Dietrich Honold 1, Sacalaz-Judet Timis 307370, RO
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Kulzer, LLC (Owner Number: 9056636)
Owner / Operator Contact Address
4315 S. Lafayette Blvd., South Bend, IN 46614, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MEMOSIL Flexitime Bite Flexitime Dynamix Heavy Tray Flexitime Dynamix Putty Flexitime Dynamix Monophase Flexitime Magnum 360 Palabond MONDIAL Mondial I Paladon 65 Artic Digital Artic Pala Digital Denture Tray Refill Pala Digital Impression Tray Universal Silicone Adhesive Pala Digital Denture Starter Kit Cuttersil Hardener Flexitime Light Flow Flexitime Medium Flow FLEXITIME MONOPHASE PRO SCAN CUTTERSIL MUCOSA FLEXITIME XTREME 2 Xantasil Palpress Vario Delara Memoreg 2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ELW Material, Impression Dental Class 2 872.3660 2013-04-11
ELW Material, Impression Dental Class 2 872.3660 2013-04-11
ELW Material, Impression Dental Class 2 872.3660 2013-04-11
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2013-04-10
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2006-09-15
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2013-06-03
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2006-09-11
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2021-01-21
ELW Material, Impression Dental Class 2 872.3660 2013-08-12
ELW Material, Impression Dental Class 2 872.3660 2013-04-11
ELW Material, Impression Dental Class 2 872.3660 2013-04-11
ELW Material, Impression Dental Class 2 872.3660 2013-04-11
ELW Material, Impression Dental Class 2 872.3660 2013-04-11
ELW Material, Impression Dental Class 2 872.3660 2013-09-09
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2014-02-24
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2019-08-16
ELW Material, Impression Dental Class 2 872.3660 2014-03-25

Official Correspondent

David Vincent

US Agent Details

David Vincent Business: Kulzer, LLC Email: david.vincent@kulzer-dental.com Phone: (574) 2995421

Related Public Records

Same Entity

Kulzer, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1821514 KULZER, LLC SOUTH BEND, IN, US
3006610834 KULZER GMBH WASSERBURG Bavaria, DE
9610902 KULZER GMBH WEHRHEIM Hesse, DE
3005665377 KULZER GMBH HANAU Hesse, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K254063 Kulzer, LLC iCEM Universal Plus 2025-12-19
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13
K800400 Dentsply Intl. MAXUM DENTURE RESIN 1980-03-12
K033020 Cmp Industries, LLC IMPAK ACRYLIC REPAIR RESIN LIQUID 2003-12-19
K070591 Union Dental S.A./Unidesa.Odi REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH 2007-05-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011203516. Last updated year: 2026. Please use registration number 3011203516 when referencing this establishment in official correspondence.
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