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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 72 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 6, D4 / R520, CE	66975646	FDA UDI	Class II	Active
Premium 6, A3 / L20, CE	66006963	FDA UDI	Class II	Unknown
Delara	66071456	FDA UDI	Class II	Active
Delara	66071375	FDA UDI	Class II	Active
Mondial 6, A3.5 / S445, CE	66016943	FDA UDI	Class II	Active
Delara	66071301	FDA UDI	Class II	Active
Mondial 8i, BL3 / M, CE	66970938	FDA UDI	Class II	Active
Mondial 6i, BL3 / L18, CE	66970695	FDA UDI	Class II	Active
Mondial 6i, A4 / L22, CE	66970566	FDA UDI	Class II	Active
Artic 6, D3 / TO 40, CE	66014071	FDA UDI	Class II	Active
Premium 6, D2 / O4, CE	66007024	FDA UDI	Class II	Unknown
Artic 6, C4 / T 15, CE	66015041	FDA UDI	Class II	Active
Mondial 6i, D3 / L16, CE	66970826	FDA UDI	Class II	Active
Artic 6, C2 / R 40, CE	66015006	FDA UDI	Class II	Active
Artic 8, D3 / 20 degree - 36 L, CE	66015248	FDA UDI	Class II	Active
Mondial 6, A2 / S451, CE	66975519	FDA UDI	Class II	Active
Basic 8, A3 / DO, CE	56739467	FDA UDI	Class II	Unknown
Mondial 6i, BL2 / S2, CE	66970666	FDA UDI	Class II	Active
Mondial 6i, D2 / L22, CE	66970808	FDA UDI	Class II	Active
Artic digital 8, B1 / 20 degree-32LD, CE	66983218	FDA UDI	Class II	Active
Mondial 6, A1 / R420, CE	66016843	FDA UDI	Class II	Active
Delara	66071316	FDA UDI	Class II	Active
Mondial 8i, BL3 / L, CE	66970940	FDA UDI	Class II	Active
Mondial 6i, A4 / L19, CE	66970564	FDA UDI	Class II	Active
Mondial 8, D2 / 30L, CE	66802185	FDA UDI	Class II	Active
Mondial 8i, D4 / 37 U, CE	66973926	FDA UDI	Class II	Active
Basic 6, C1 / U06, CE	56739330	FDA UDI	Class II	Unknown
Mondial 6, B4 / S445, CE	66017083	FDA UDI	Class II	Active
Artic 6, A3.5 / O 10, CE	66012871	FDA UDI	Class II	Active
Basic 6, A3.5 / A11, CE	56739020	FDA UDI	Class II	Unknown
Mondial 8i, BL2 / 33 U, CE	66973858	FDA UDI	Class II	Active
Mondial 8i, A1 / 37L, CE	66973791	FDA UDI	Class II	Active
Artic 6, B1 / L 25, CE	66014936	FDA UDI	Class II	Active
dima	66075560	FDA UDI	Class II	Active
Premium 6, B2 / L18, CE	66006951	FDA UDI	Class II	Unknown
Mondial 8i, A1 / S, CE	66970856	FDA UDI	Class II	Active
Artic 6, C1 / T 15, CE	66014993	FDA UDI	Class II	Active
Premium 6, D2 / L20, CE	66006974	FDA UDI	Class II	Unknown
Mondial 6, A1 / T465, CE	66016850	FDA UDI	Class II	Active
Mondial 8 DS, A1 / 33L, CE	66986620	FDA UDI	Class II	Unknown
Artic	66080364	FDA UDI	Class II	Active
Artic	66080526	FDA UDI	Class II	Active
Delara	66071373	FDA UDI	Class II	Active
Delara	66071292	FDA UDI	Class II	Active
VENUS DIAMOND SYRINGE REFILL 1x4G CL	66035490	FDA UDI	Class II	Active
Premium 8, A2 / L, CE	66007188	FDA UDI	Class II	Unknown
Premium 8, A3.5 / XS, CE	66007286	FDA UDI	Class II	Unknown
Artic	66080418	FDA UDI	Class II	Active
Artic 6, B3 / L 15, CE	66014967	FDA UDI	Class II	Active
Artic	66080371	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