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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 29 of 123

Device	Model / Reference	Registries	Class	Status
VENUS Diamond FLOW PLT 20x0, 20G - Base	66041051	FDA UDI	Class II	Active
Basic 8, C2 / BO, CE	56739411	FDA UDI	Class II	Unknown
Mondial 6, C4 / S451, CE	66975623	FDA UDI	Class II	Active
Mondial 8i, D4 / 33 U, CE	66973922	FDA UDI	Class II	Active
Mondial 6 DS, A3 / O510, CE	66985645	FDA UDI	Class II	Unknown
Delara	66071596	FDA UDI	Class II	Active
Artic	66080444	FDA UDI	Class II	Active
Delara	66071372	FDA UDI	Class II	Active
Palapress Vario	64707864	FDA UDI	Class II	Active
Basic 6, A3.5 / U06, CE	56739324	FDA UDI	Class II	Unknown
Artic 6, C1 / S 40, CE	66013995	FDA UDI	Class II	Active
Mondial 6, D2 / S443, CE	66017222	FDA UDI	Class II	Active
Artic 6, B1 / TO 10, CE	66014932	FDA UDI	Class II	Active
Premium 6, A1 / L14, CE	66006913	FDA UDI	Class II	Unknown
Basic 6, B1 / A13, CE	56739054	FDA UDI	Class II	Unknown
Charisma	66000112	FDA UDI	Class II	Active
Mondial 6, BL1 / T465, CE	66801007	FDA UDI	Class II	Unknown
VENUS DIAMOND SYRINGE REFILL 1x4G HKA5	66035477	FDA UDI	Class II	Active
Delara	66071279	FDA UDI	Class II	Active
Delara	66071539	FDA UDI	Class II	Active
Mondial 6, A2 / T435, CE	66975522	FDA UDI	Class II	Active
Mondial 6, B3 / S445, CE	66017055	FDA UDI	Class II	Active
Artic 6, C2 / T 30, CE	66012860	FDA UDI	Class II	Active
Dima	66081676	FDA UDI	Class II	Active
Mondial 6i, A4 / L14, CE	66970561	FDA UDI	Class II	Active
Artic 6, C1 / T 40, CE	66014031	FDA UDI	Class II	Active
Basic 8, B1 / GU, CE	56739518	FDA UDI	Class II	Unknown
Venus Pearl	66048200	FDA UDI	Class II	Active
Delara	66071305	FDA UDI	Class II	Active
Premium 8, A4 / LL, CE	66007207	FDA UDI	Class II	Unknown
Mondial 6i DS, A3.5 / R2, CE	66986285	FDA UDI	Class II	Unknown
Premium 6, C4 / S4, CE	66007119	FDA UDI	Class II	Unknown
Artic	66080300	FDA UDI	Class II	Active
Mondial 8i DS, A1 / 35 U, CE	66986805	FDA UDI	Class II	Unknown
Mondial 6, B2 / R483, CE	66017015	FDA UDI	Class II	Active
Artic 6, D3 / S 05, CE	66015071	FDA UDI	Class II	Active
Delara	66071288	FDA UDI	Class II	Active
Artic	66080539	FDA UDI	Class II	Active
Mondial 6, A3.5 / L398, CE	66016954	FDA UDI	Class II	Active
Basic 6, A3.5 / L03, CE	56739100	FDA UDI	Class II	Unknown
Basic 8, B4 / CO, CE	56739441	FDA UDI	Class II	Unknown
Basic 8, A1 / GU, CE	56739513	FDA UDI	Class II	Unknown
Artic	66080752	FDA UDI	Class II	Active
Delara	66071680	FDA UDI	Class II	Active
Mondial 8, B4 / 30L, CE	66802155	FDA UDI	Class II	Active
Mondial 8 DS, A3.5 / 33L, CE	66986650	FDA UDI	Class II	Unknown
Durafill VS	66000018	FDA UDI	Class II	Active
Mondial 6, D2 / O457, CE	66017219	FDA UDI	Class II	Active
Premium 8, B1 / S, CE	66007256	FDA UDI	Class II	Unknown
Mondial 6i, A4 / O2, CE	66970553	FDA UDI	Class II	Active

Related Companies

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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