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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 60 of 123

Device	Model / Reference	Registries	Class	Status
Artic 6, B1 / T 10, CE	66012844	FDA UDI	Class II	Active
Mondial 6, D2 / O444, CE	66017218	FDA UDI	Class II	Active
Mondial 6, A4 / R420, CE	66016956	FDA UDI	Class II	Active
Delara	66071469	FDA UDI	Class II	Active
Premium 8, A4 / L, CE	66007191	FDA UDI	Class II	Unknown
Mondial 6, C3 / R455, CE	66017154	FDA UDI	Class II	Active
Artic 8, A3.5 / 30 degree - 32 L, CE	66037016	FDA UDI	Class II	Active
Artic 6, C1 / O 20, CE	66014049	FDA UDI	Class II	Active
Delara	66071459	FDA UDI	Class II	Active
Artic	66080592	FDA UDI	Class II	Active
Delara	66071557	FDA UDI	Class II	Active
Venus Pearl	66048148	FDA UDI	Class II	Active
Venus Temp 2 Cartridge Refill A1	66049181	FDA UDI	Class II	Unknown
Basic 8, D3 / HO, CE	56739543	FDA UDI	Class II	Unknown
Artic digital 6, A2 / L20D, CE	66983019	FDA UDI	Class II	Active
Mondial 6i, C2 / R6, CE	66970724	FDA UDI	Class II	Active
Artic 6, B4 / O 10, CE	66014039	FDA UDI	Class II	Active
Artic 8, B1 / 10 degree - 30 U, CE	66015153	FDA UDI	Class II	Active
Mondial 6, A4 / L382, CE	66016980	FDA UDI	Class II	Active
Venus Pearl	66048165	FDA UDI	Class II	Active
Delara	66071655	FDA UDI	Class II	Active
Sopira Citoject Set 1.8ml/Inch Flat La	66002392	FDA UDI	Class II	Active
Xantasil	66067514	FDA UDI	Class II	Active
Premium 6, A3 / O6, CE	66007029	FDA UDI	Class II	Unknown
Basic 6, D4 / A13, CE	56739064	FDA UDI	Class II	Unknown
Signum Opaque F	66020072	FDA UDI	Class II	Active
Mondial 6i, C2 / O2, CE	66970729	FDA UDI	Class II	Active
Mondial 8i, B2 / L, CE	66970908	FDA UDI	Class II	Active
Artic digital 6, B1 / R40D, CE	66983058	FDA UDI	Class II	Active
Mondial 6, A3 / T452, CE	66975532	FDA UDI	Class II	Active
Basic 6, A2 / U02, CE	56739258	FDA UDI	Class II	Unknown
Premium 6, C4 / T6, CE	66007183	FDA UDI	Class II	Unknown
Delara	66071157	FDA UDI	Class II	Active
Basic 8, C2 / HU, CE	56739555	FDA UDI	Class II	Unknown
PalaXpress ultra, R50 veined, 1000g	66034254	FDA UDI	Class II	Unknown
Artic 8, C2 / 20 degree - 32 U, CE	66012951	FDA UDI	Class II	Active
Delara	66071272	FDA UDI	Class II	Active
Ibond Self Etch Bottle Value Pack	66046243	FDA UDI	Class II	Unknown
Mondial 8i, A4 / 37 U, CE	66973822	FDA UDI	Class II	Active
Mondial 6, BL1 / L369, CE	66801014	FDA UDI	Class II	Unknown
Mondial 6i, D3 / L19, CE	66970828	FDA UDI	Class II	Active
Mondial 6i, B3 / L18, CE	66970629	FDA UDI	Class II	Active
Mondial 6i, A4 / R6, CE	66970548	FDA UDI	Class II	Active
Mondial 6, B1 / T465, CE	66016991	FDA UDI	Class II	Active
Delara	66071322	FDA UDI	Class II	Active
Mondial 6i, BL2 / O2, CE	66970663	FDA UDI	Class II	Active
Artic 6, C2 / O 20, CE	66012881	FDA UDI	Class II	Active
Artic 8, B4 / 20 degree - 30 L, CE	66014129	FDA UDI	Class II	Active
Artic 6, D4 / TO 05, CE	66015091	FDA UDI	Class II	Active
Artic 8, D4 / 10 degree - 30 U, CE	66015253	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