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Kulzer, Inc.

Last updated September 17, 2026

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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Kulzer, Inc. manufacture?

Kulzer, Inc. specializes in dental materials and systems. Their portfolio includes resin artificial teeth, dental composite resins, veneer resins for dental prostheses, polyether impression materials for dental impressions, and laboratory CAD/CAM dental milling systems. They also produce dentine bonding agents and specialized resins for restorative and prosthetic dental applications, all designed for use in dental procedures.

Where is Kulzer, Inc. based?

Kulzer, Inc. is headquartered in the United States. The company focuses on developing and manufacturing dental materials and systems primarily for use in clinical and laboratory settings.

Which regulatory registries list Kulzer, Inc.’s devices?

Kulzer, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

How are Kulzer, Inc.’s devices classified under medical device regulations?

Kulzer, Inc.’s devices fall under Class II medical device classification. This classification applies to products that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as dental materials and systems used in restorative or prosthetic procedures.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 4315 S. Lafayette Blvd., SOUTH BEND, IN, 46614
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1821514
DUNS Number: —

Catalogue (6131)

Page 40 of 123

Device	Model / Reference	Registries	Class	Status
Premium 6, B2 / L20, CE	66006967	FDA UDI	Class II	Unknown
Premium 6, A4 / O6, CE	66007031	FDA UDI	Class II	Unknown
Artic 6, C4 / L 55, CE	66015050	FDA UDI	Class II	Active
Delara	66071396	FDA UDI	Class II	Active
Artic 6, D4 / L 50, CE	66014117	FDA UDI	Class II	Active
Mondial 6i DS, A1 / L20, CE	66986238	FDA UDI	Class II	Unknown
Mondial 6, A2 / T450, CE	66016878	FDA UDI	Class II	Active
Mondial 6, A2 / L378, CE	66016895	FDA UDI	Class II	Active
Delara	66071479	FDA UDI	Class II	Active
Signum cre-active	66020051	FDA UDI	Class II	Active
Mondial 6i, B3 / L16, CE	66970628	FDA UDI	Class II	Active
Mondial 8i, BL3 / 31 U, CE	66973864	FDA UDI	Class II	Active
Artic 6, A3 / R 30, CE	66014877	FDA UDI	Class II	Active
Artic 6, A3 / TO 10, CE	66014884	FDA UDI	Class II	Active
Mondial 6, A4 / L373, CE	66016978	FDA UDI	Class II	Active
Mondial 8, C2 / 35 U, CE	66017397	FDA UDI	Class II	Active
Signum composite flow	66049053	FDA UDI	Class II	Active
Artic	66080538	FDA UDI	Class II	Active
Cutter Hardener Universal Plus Liquid	66037446	FDA UDI	Class II	Active
Premium 6, A4 / L20, CE	66006965	FDA UDI	Class II	Unknown
Delara	66071296	FDA UDI	Class II	Active
Premium 6, A4 / L22, CE	66006982	FDA UDI	Class II	Unknown
Artic 6, B3 / S 40, CE	66013993	FDA UDI	Class II	Active
Cara	66069511	FDA UDI	Class II	Unknown
Artic	66080483	FDA UDI	Class II	Active
Artic digital 6, B4 / TO30D, CE	66080447	FDA UDI	Class II	Active
Delara	66071618	FDA UDI	Class II	Active
Artic	66080264	FDA UDI	Class II	Active
Mondial 6i, C1 / L20, CE	66970719	FDA UDI	Class II	Active
Artic 8, C2 / 0 degree - 32 L, CE	66015202	FDA UDI	Class II	Active
Delara	66071531	FDA UDI	Class II	Active
Mondial 6, A2 / S550, CE	66975521	FDA UDI	Class II	Active
Artic digital 6, B3 / S40D, CE	66983082	FDA UDI	Class II	Active
Mondial 8i Returns	40005801	FDA UDI	Class II	Unknown
Artic 6, C2 / TO 20, CE	66015013	FDA UDI	Class II	Active
Artic digital 8, B1 / 20 degree-32 UD, CE	66983217	FDA UDI	Class II	Active
Mondial 6i, C2 / L24, CE	66970743	FDA UDI	Class II	Active
Mondial 6 DS, B1 / T477, CE	66985774	FDA UDI	Class II	Unknown
Flexitime Light Flow 1x50ml Sample	66077377	FDA UDI	Class II	Active
Mondial 6, BL3 / L331, CE	66801067	FDA UDI	Class II	Active
Artic	66080734	FDA UDI	Class II	Active
Mondial 6, C4 / S502, CE	66975624	FDA UDI	Class II	Active
Artic 6, C2 / L 20, CE	66012909	FDA UDI	Class II	Active
Artic 8, B1 / 30 degree - 32 U, CE	66037027	FDA UDI	Class II	Active
Mondial 6, D4 / R410, CE	66017263	FDA UDI	Class II	Active
Artic digital 6, A4 / R40D, CE	66983047	FDA UDI	Class II	Active
Delara	66071605	FDA UDI	Class II	Active
Premium 6, D4 / L12, CE	66006912	FDA UDI	Class II	Unknown
Delara	66071307	FDA UDI	Class II	Active
Artic	66080440	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Authorities

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FDA Establishments (2)

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

Kulzer Gmbh HANAU Hesse · DE FEI 3005665377
Kulzer SRL Sacalaz-Judet Timis · RO FEI 3011203516