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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 71 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 6, B4 / T405, CE	66017072	FDA UDI	Class II	Active
Artic digital 6, A2 / TO20D, CE	66983018	FDA UDI	Class II	Active
Mondial 6i, A3.5 / L22, CE	66970544	FDA UDI	Class II	Active
Mondial 6i, C1 / T6, CE	66970706	FDA UDI	Class II	Active
Artic	66080480	FDA UDI	Class II	Active
Mondial 8, B3 / 32 U, CE	66802150	FDA UDI	Class II	Active
Premium 6, A2 / L12, CE	66006898	FDA UDI	Class II	Unknown
Premium 8, B2 / LL, CE	66007209	FDA UDI	Class II	Unknown
Premium 6, B1 / R4, CE	66007064	FDA UDI	Class II	Unknown
Premium 8, B4 / ML, CE	66007243	FDA UDI	Class II	Unknown
Artic 6, C4 / L 40, CE	66014105	FDA UDI	Class II	Active
Artic 6, C4 / T 30, CE	66014024	FDA UDI	Class II	Active
Premium 8, D2 / L, CE	66007200	FDA UDI	Class II	Unknown
Mondial 8i, C4 / S, CE	66970968	FDA UDI	Class II	Active
Artic digital 8, A3 / 20 degree-32LD, CE	66983200	FDA UDI	Class II	Active
Artic 8, C3 / 20 degree - 30 U, CE	66014122	FDA UDI	Class II	Active
Delara	66071287	FDA UDI	Class II	Active
Venus Diamond	66098261	FDA UDI	Class II	Active
Premium 6, A2 / O4, CE	66007012	FDA UDI	Class II	Unknown
Mondial 6i, C3 / L14, CE	66970759	FDA UDI	Class II	Active
Delara	66071389	FDA UDI	Class II	Active
Premium 6, A1 / O2, CE	66006994	FDA UDI	Class II	Unknown
Artic digital 6, B2 / T15D, CE	66080397	FDA UDI	Class II	Active
Mondial 6, A3 / S453, CE	66016916	FDA UDI	Class II	Active
Delara	66071392	FDA UDI	Class II	Active
Delara	66071473	FDA UDI	Class II	Active
Mondial 8i DS, A3 / 33 U, CE	66986835	FDA UDI	Class II	Unknown
Delara	66071298	FDA UDI	Class II	Active
HeraCeram Pastenopakerpinsel	66004002	FDA UDI	Class II	Unknown
Mondial 8i, D2 / 31L, CE	66973905	FDA UDI	Class II	Active
Artic	66080481	FDA UDI	Class II	Active
Delara	66071571	FDA UDI	Class II	Active
Venus Pearl	66048162	FDA UDI	Class II	Active
Mondial 8i, B1 / 35L, CE	66973829	FDA UDI	Class II	Active
Mondial 8, A2 / 37L, CE	66017310	FDA UDI	Class II	Active
Mondial 8i, C3 / XSL, CE	66970959	FDA UDI	Class II	Active
Artic	66080569	FDA UDI	Class II	Active
Artic digital 8, C3 / 10 degrees-32 UD, CE	66080748	FDA UDI	Class II	Active
Venus Diamond Plt Basic Kit + Ibte	66055476	FDA UDI	Class II	Unknown
Basic 8, A2 / BO, CE	56739402	FDA UDI	Class II	Unknown
Signum composite	66020015	FDA UDI	Class II	Active
Mondial 8i, A2 / L, CE	66970868	FDA UDI	Class II	Active
Basic 6, A4 / P22, CE	56739213	FDA UDI	Class II	Unknown
Mondial 8i, A4 / 33 U, CE	66973818	FDA UDI	Class II	Active
Venus Temp 2 Cartridge Refill B1	66049184	FDA UDI	Class II	Unknown
Delara	66071275	FDA UDI	Class II	Active
Mondial 6, A3 / L382, CE	66016924	FDA UDI	Class II	Active
Delara	66071616	FDA UDI	Class II	Active
Mondial 6, A3.5 / O525, CE	66016941	FDA UDI	Class II	Active
Mondial 6 DS, A2 / O510, CE	66985609	FDA UDI	Class II	Unknown

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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