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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 70 of 123

Device	Model / Reference	Registries	Class	Status
Artic digital 8, C2 / 20 degree-36LD, CE	66983258	FDA UDI	Class II	Active
Premium 8, C3 / SL, CE	66007278	FDA UDI	Class II	Unknown
Mondial 8i, D2 / L, CE	66970980	FDA UDI	Class II	Active
Mondial 8i, A3.5 / 37L, CE	66973815	FDA UDI	Class II	Active
Mondial 8i, B4 / 31 U, CE	66973848	FDA UDI	Class II	Active
Artic 8, D4 / 30 degree - 34 U, CE	66037089	FDA UDI	Class II	Active
Basic 8, B4 / FU, CE	56739617	FDA UDI	Class II	Unknown
Artic digital 8, C1 / 20 degree-32LD, CE	66983248	FDA UDI	Class II	Active
Delara	66071191	FDA UDI	Class II	Active
Mondial 6, B4 / T442, CE	66017073	FDA UDI	Class II	Active
Delara	66071262	FDA UDI	Class II	Active
Basic 8, A1 / HO, CE	56739529	FDA UDI	Class II	Unknown
Mondial 8, B1 / 37L, CE	66017350	FDA UDI	Class II	Active
Premium 6, A4 / L12, CE	66006901	FDA UDI	Class II	Unknown
Basic 6, C1 / A12, CE	56739042	FDA UDI	Class II	Unknown
Artic 6, D2 / L 30, CE	66014097	FDA UDI	Class II	Active
Artic 6, C3 / T 20, CE	66014014	FDA UDI	Class II	Active
Mondial 6i, B3 / L12, CE	66970626	FDA UDI	Class II	Active
Artic 8, C3 / 20 degree - 36 U, CE	66015217	FDA UDI	Class II	Active
Artic 6, D2 / S 05, CE	66015055	FDA UDI	Class II	Active
Mondial 6i, B2 / L16, CE	66970606	FDA UDI	Class II	Active
Mondial 6i, A4 / T6, CE	66970552	FDA UDI	Class II	Active
Delara	66071671	FDA UDI	Class II	Active
Basic 6, A3.5 / L06, CE	56739148	FDA UDI	Class II	Unknown
Artic	66080627	FDA UDI	Class II	Active
Mondial 8i, A1 / M, CE	66970858	FDA UDI	Class II	Active
VENUS DIAMOND SYRINGE REFILL 1x4G D3	66035483	FDA UDI	Class II	Active
Mondial 6, A4 / R520, CE	66975542	FDA UDI	Class II	Active
Basic 6, A3.5 / L02, CE	56739084	FDA UDI	Class II	Unknown
Basic 8, B3 / BO, CE	56739408	FDA UDI	Class II	Unknown
Basic 8, C1 / GO, CE	56739506	FDA UDI	Class II	Unknown
Basic 6, B2 / U02, CE	56739263	FDA UDI	Class II	Unknown
Delara	66071480	FDA UDI	Class II	Active
Artic 6, A3 / T 15, CE	66014881	FDA UDI	Class II	Active
Artic 6, D3 / S 30, CE	66013990	FDA UDI	Class II	Active
Mondial 6, D4 / L315, CE	66017281	FDA UDI	Class II	Active
Basic 8, C4 / FU, CE	56739621	FDA UDI	Class II	Unknown
Mondial 8i, D3 / 33 U, CE	66973914	FDA UDI	Class II	Active
Mondial 6i, D4 / S4, CE	66970843	FDA UDI	Class II	Active
Artic digital 6, B2 / L20D, CE	66983074	FDA UDI	Class II	Active
Mondial 8, BL1 / 32 U, CE	66802204	FDA UDI	Class II	Unknown
Mondial 6, D4 / T465, CE	66017271	FDA UDI	Class II	Active
Venus Diamond	66096874	FDA UDI	Class II	Active
Artic digital 6, C3 / S30D, CE	66983136	FDA UDI	Class II	Active
Venus Pearl	66096876	FDA UDI	Class II	Active
Mondial 8, A2 / 35 U, CE	66017307	FDA UDI	Class II	Active
Basic 8, A1 / HU, CE	56739545	FDA UDI	Class II	Unknown
Artic 6, C3 / TO 20, CE	66015029	FDA UDI	Class II	Active
Mondial 6, D2 / T515, CE	66017217	FDA UDI	Class II	Active
Mondial 8, A3 / 33 U, CE	66017315	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