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Kulzer, Inc.

Also registered as Kulzer, LLC

United Statesfrom the FDA registration address FDA FEI 1821514

Devices
38
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Kulzer, Inc. makes

Kulzer, Inc. manufactures dental materials including resin artificial teeth, dental composite resins, veneer resins for prostheses, polyether impression materials, and laboratory CAD/CAM dental milling systems. Their portfolio also includes dentine bonding agents and specialized dental resins for restorative and prosthetic applications.

The company’s products are classified as Class II medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. Kulzer, Inc. is based in the United States.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue38

Newest first, rows 1-38 of 38

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  • Palapress(R) Vario Resin Ref K902115

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • dima Print Teeth & Temp Ref K233868

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Denthesive Ref K905302

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Retraxil Ref K243910

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Silicoater Md Ref K910719

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kulzer Glas-Ionomer Cement Ref K892453

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Durafill Color Vs Ref K905131

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Dentalon Plus Ref K903317

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Palatray Lc Resin Impression Tray Material Ref K902350

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Paladon(R) 65 Ref K901789

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kulzer Dentin Adhesive Ref K850965

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Formasil(R)A Polyvinyl Siloxane Line Ref K901681

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kulzer Inlay System Ref K892454

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One Ref K260783

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Heraeus' Heragam 48, Non Gamma 2 Den. Amal. Alloy Ref K875344

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Microfill Pontic Ref K862546

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Multifil(R) Vs Ref K863315

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Dentalon Ref K831077

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Estic Microfill Ref K840176

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Durafill Microfill Restorative Material Ref K811669

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active Ref K240660

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Signum opaque F Ref K230644

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Estilux Posterior Ref K812889

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kulzer Translux Visible Light Curing Ref K811668

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Silistor Ceramic And Resin Repair System Ref K901697

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kulzer Adhesive Cement Ref K892455

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Charisma Ref K910263

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • iCEM Universal Plus Ref K254063

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Estilux Posterior Xr Ref K813568

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Palaseal(R) Ref K892452

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Venus Bulk Flow ONE Ref K220605

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Durafill Flow Ref K904555

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kulzer Translux Ec Ref K892456

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Translux Cl Ref K843823

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Dentacolor Light Curing Crown & Bridge Ref K831215

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Estilux(R) Posterior C Ref K863314

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Palavit Glc Ref K904928

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Palavit L Ref K905058

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-38 of 38

Company details

FDA FEI number
1821514
Address
4315 S. Lafayette Blvd., SOUTH BEND, IN, 46614

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Kulzer SRL Sacalaz-Judet Timis · RO FEI 3011203516

Frequently asked questions

How many devices does Kulzer, Inc. have in the registry?

The registry currently lists 38 devices for Kulzer, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Kulzer, Inc.'s devices?

Among its 38 most recently registered devices, Kulzer, Inc. has devices listed in FDA 510(k) (38 devices).

What risk classes do Kulzer, Inc.'s devices fall under?

Among its 38 most recently registered devices, the classes recorded for Kulzer, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Kulzer, Inc. in the registry?

The most recently registered devices listed for Kulzer, Inc. include PALAPRESS(R) VARIO RESIN, dima Print Teeth & Temp, DENTHESIVE and Retraxil.

Which FDA establishments are linked to Kulzer, Inc.?

1 FDA establishment is linked to Kulzer, Inc. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.