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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 36 of 123

Device	Model / Reference	Registries	Class	Status
PalaXpress ultra, pink, 12000g	66046221	FDA UDI	Class II	Unknown
Basic 6, A1 / U01, CE	56739241	FDA UDI	Class II	Unknown
HC-Zirkonia Dentin DA2, 100g	66042082	FDA UDI	Class II	Unknown
Mondial 6, D2 / L384, CE	66017233	FDA UDI	Class II	Active
Premium 6, BL2 / S6, CE	66802941	FDA UDI	Class II	Unknown
Premium 6, BL3 / T2, CE	66802951	FDA UDI	Class II	Unknown
Artic digital 8, A4 / 20 degree-34 UD, CE	66983213	FDA UDI	Class II	Active
Venus Bulk Flow ONE	66095388	FDA UDI	Class II	Active
Dima	66087417	FDA UDI	Class II	Active
iBOND Total Etch Single Dose Value Pack	66039870	FDA UDI	Class II	Active
Basic 6, C4 / P22, CE	56739221	FDA UDI	Class II	Unknown
Artic 6, C1 / L 25, CE	66015000	FDA UDI	Class II	Active
Mondial 8i, C4 / SL, CE	66970969	FDA UDI	Class II	Active
Mondial 8i, A4 / S, CE	66970888	FDA UDI	Class II	Active
Premium 6, A3.5 / L20, CE	66006964	FDA UDI	Class II	Unknown
Delara	66071555	FDA UDI	Class II	Active
IBOND SELF ETCH BOTTLE SAMPLE 1 x 2ML	66048261	FDA UDI	Class II	Unknown
Basic 6, A3.5 / P21, CE	56739196	FDA UDI	Class II	Unknown
Basic 8, C4 / BU, CE	56739429	FDA UDI	Class II	Unknown
Basic 6, C2 / U02, CE	56739267	FDA UDI	Class II	Unknown
Basic 6, A3 / L05, CE	56739131	FDA UDI	Class II	Unknown
Basic 6, A1 / U02, CE	56739257	FDA UDI	Class II	Unknown
Artic 8, A2 / 10 degree - 30 U, CE	66015113	FDA UDI	Class II	Active
Premium 6, A3 / O4, CE	66007013	FDA UDI	Class II	Unknown
Basic 6, C3 / U03, CE	56739284	FDA UDI	Class II	Unknown
Delara	66071321	FDA UDI	Class II	Active
Mondial 8i, A2 / 37L, CE	66973799	FDA UDI	Class II	Active
Mondial 6, BL1 / S453, CE	66801003	FDA UDI	Class II	Unknown
Signum cre-active	66020060	FDA UDI	Class II	Active
Basic 6, C1 / L04, CE	56739122	FDA UDI	Class II	Unknown
Mondial 6i DS, A2 / O4, CE	66986249	FDA UDI	Class II	Unknown
Artic 8, BL3 / 30 degree - 30 U, CE	66970452	FDA UDI	Class II	Active
Mondial 6i, C1 / S6, CE	66970712	FDA UDI	Class II	Active
Mondial 6i, D3 / R2, CE	66970810	FDA UDI	Class II	Active
Delara	66071587	FDA UDI	Class II	Active
Premium 6, A1 / O6, CE	66007027	FDA UDI	Class II	Unknown
HeraCeram Schultermasse HM4, 20g	66003490	FDA UDI	Class II	Unknown
Premium 8, D4 / XSL, CE	66007314	FDA UDI	Class II	Unknown
Mondial 6 DS, B1 / L382, CE	66985784	FDA UDI	Class II	Unknown
Mondial 6, B3 / O457, CE	66017051	FDA UDI	Class II	Active
Mondial 8i, B1 / SL, CE	66970897	FDA UDI	Class II	Active
Mondial 6i, BL3 / O4, CE	66970686	FDA UDI	Class II	Active
Mondial 8i, B3 / 37L, CE	66973847	FDA UDI	Class II	Active
Artic 6, C1 / S 30, CE	66013986	FDA UDI	Class II	Active
Durafill VS	66000012	FDA UDI	Class II	Active
Artic 6, A3.5 / T 30, CE	66012857	FDA UDI	Class II	Active
HC-Zirkonia Dentin DA3, 5, 20g	66020191	FDA UDI	Class II	Unknown
Premium 6, BL3 / T6, CE	66802953	FDA UDI	Class II	Unknown
PALA cre-active, polar, 3 g	66033448	FDA UDI	Class II	Active
PALA cre-active, gingiva, R 50, 3 g	66033465	FDA UDI	Class II	Active

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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