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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 35 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 6i, D4 / R6, CE	66970834	FDA UDI	Class II	Active
Premium 8, B2 / S, CE	66007257	FDA UDI	Class II	Unknown
Mondial I Living Mould Chart A1	66053276	FDA UDI	Class II	Unknown
Artic 6, B3 / TO 05, CE	66014963	FDA UDI	Class II	Active
Mondial 6, A3 / T465, CE	66016907	FDA UDI	Class II	Active
Artic	66080262	FDA UDI	Class II	Active
Mondial 6i, B2 / T4, CE	66970595	FDA UDI	Class II	Active
Artic	66080414	FDA UDI	Class II	Active
PalaXpress ultra pink opaque, 12000g	66051902	FDA UDI	Class II	Unknown
Mondial 8i, C2 / SL, CE	66970953	FDA UDI	Class II	Active
Mondial 8i, C4 / M, CE	66970970	FDA UDI	Class II	Active
Mondial 8i, A3 / 35L, CE	66973805	FDA UDI	Class II	Active
Mondial 6i, B1 / S2, CE	66970578	FDA UDI	Class II	Active
Mondial 6, D2 / S451, CE	66975631	FDA UDI	Class II	Active
Delara	66071255	FDA UDI	Class II	Active
Mondial 8i, B2 / LL, CE	66970909	FDA UDI	Class II	Active
Mondial 6i, A1 / O6, CE	66970467	FDA UDI	Class II	Active
Mondial 6i, BL3 / R6, CE	66970680	FDA UDI	Class II	Active
Mondial 6, B3 / T515, CE	66017049	FDA UDI	Class II	Active
Artic 6, A3 / R 20, CE	66014876	FDA UDI	Class II	Active
Mondial 6, A3 / L331, CE	66016918	FDA UDI	Class II	Active
Artic 6, C2 / TO 30, CE	66012888	FDA UDI	Class II	Active
Premium 8, D3 / S, CE	66007265	FDA UDI	Class II	Unknown
Artic 8, A3 / 30 degree - 32 U, CE	66037009	FDA UDI	Class II	Active
Artic	66080503	FDA UDI	Class II	Active
Mondial 8, A2 / 37 U, CE	66017309	FDA UDI	Class II	Active
Venus Pearl	66048201	FDA UDI	Class II	Active
Delara	66071367	FDA UDI	Class II	Active
Venus Diamond	66039021	FDA UDI	Class II	Active
Delara	66071600	FDA UDI	Class II	Active
Mondial 6, C3 / T515, CE	66017161	FDA UDI	Class II	Active
Artic 6, C4 / TO 40, CE	66014069	FDA UDI	Class II	Active
Mondial 6i, B4 / L16, CE	66970650	FDA UDI	Class II	Active
Mondial 8i DS, B1 / 37 U, CE	66986887	FDA UDI	Class II	Unknown
Basic 6, D4 / L06, CE	56739160	FDA UDI	Class II	Unknown
Charisma ABC	66064796	FDA UDI	Class II	Active
Artic 6, A3 / L 40, CE	66012919	FDA UDI	Class II	Active
Delara	66071432	FDA UDI	Class II	Active
VENUS FLOW SYR 1 x 1, 8G - SBO	66014573	FDA UDI	Class II	Unknown
Mondial 6i, D3 / T6, CE	66970816	FDA UDI	Class II	Active
Artic 8, C1 / 10 degree - 30 L, CE	66015194	FDA UDI	Class II	Active
Premium 6, A4 / T6, CE	66007175	FDA UDI	Class II	Unknown
Delara	66071611	FDA UDI	Class II	Active
Mondial 6, BL1 / L378, CE	66801016	FDA UDI	Class II	Unknown
Mondial 6i, BL2 / L14, CE	66970671	FDA UDI	Class II	Active
Mondial 6i Returns	40005800	FDA UDI	Class II	Unknown
Mondial 8, A4 / 31L, CE	66017334	FDA UDI	Class II	Active
Artic	66080305	FDA UDI	Class II	Active
Artic 8, C1 / 30 degree - 32 U, CE	66037051	FDA UDI	Class II	Active
Delara	66071412	FDA UDI	Class II	Active

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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