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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 39 of 123

Device	Model / Reference	Registries	Class	Status
VENUS Diamond FLOW PLT 20x0, 20g - B2	66040375	FDA UDI	Class II	Active
Mondial 8, B1 / 32 U, CE	66802138	FDA UDI	Class II	Active
Mondial 6i, A1 / S8, CE	66970471	FDA UDI	Class II	Active
Premium 8, BL2 / XSL, CE	66802993	FDA UDI	Class II	Unknown
Basic 6, A4 / P23, CE	56739229	FDA UDI	Class II	Unknown
Mondial 6, C1 / L382, CE	66017120	FDA UDI	Class II	Active
Artic	66080312	FDA UDI	Class II	Active
Delara	66071240	FDA UDI	Class II	Active
iBOND Etch 35 Fluid	66039868	FDA UDI	Class II	Active
Mondial 6i, B3 / R6, CE	66970614	FDA UDI	Class II	Active
Premium 8, A3.5 / LL, CE	66007206	FDA UDI	Class II	Unknown
Artic 8, B1 / 10 degree - 30 L, CE	66015154	FDA UDI	Class II	Active
Premium 6, C3 / R2, CE	66007054	FDA UDI	Class II	Unknown
Artic 8, D4 / 0 degree - 32 L, CE	66015252	FDA UDI	Class II	Active
Artic digital 6, A2 / O30D, CE	66983011	FDA UDI	Class II	Active
Mondial 8, A4 / 37 U, CE	66017339	FDA UDI	Class II	Active
Premium 6, A3.5 / O2, CE	66006997	FDA UDI	Class II	Unknown
Mondial 8i, D3 / ML, CE	66970987	FDA UDI	Class II	Active
Artic 8, D2 / 30 degree - 30 U, CE	66037073	FDA UDI	Class II	Active
Mondial 6, A2 / L382, CE	66016896	FDA UDI	Class II	Active
Mondial 6i, C4 / L14, CE	66970781	FDA UDI	Class II	Active
Mondial 6, B4 / L384, CE	66017093	FDA UDI	Class II	Active
Artic 8, B3 / 30 degree - 30 U, CE	66037037	FDA UDI	Class II	Active
Premium 6, B4 / L12, CE	66006905	FDA UDI	Class II	Unknown
Mondial 6, C3 / L378, CE	66017175	FDA UDI	Class II	Active
VENUS Diamond FLOW PLT 20x0, 20g - BXL	66040378	FDA UDI	Class II	Active
Basic 6, B3 / U02, CE	56739264	FDA UDI	Class II	Unknown
Artic 6, A3 / L 50, CE	66012926	FDA UDI	Class II	Active
Premium 8, B2 / SL, CE	66007273	FDA UDI	Class II	Unknown
Mondial 6, BL2 / T442, CE	66801033	FDA UDI	Class II	Active
Mondial 6, B2 / S445, CE	66017027	FDA UDI	Class II	Active
Mondial 6i, BL3 / R4, CE	66970679	FDA UDI	Class II	Active
Artic	66080725	FDA UDI	Class II	Active
Artic	66080563	FDA UDI	Class II	Active
Signum composite flow	66049054	FDA UDI	Class II	Active
Mondial 6, B3 / T405, CE	66017044	FDA UDI	Class II	Active
Flexitime Xtreme 2 Correct Flow 12 pc	66050335	FDA UDI	Class II	Active
Mondial 8, A2 / 31L, CE	66017304	FDA UDI	Class II	Active
Mondial 6, C2 / L331, CE	66017142	FDA UDI	Class II	Active
Basic 8, A1 / EO, CE	56739561	FDA UDI	Class II	Unknown
Mondial 6i, A3 / O2, CE	66970509	FDA UDI	Class II	Active
Delara	66071689	FDA UDI	Class II	Active
Mondial 6, C1 / R483, CE	66017099	FDA UDI	Class II	Active
Artic 6, B2 / TO 30, CE	66012887	FDA UDI	Class II	Active
Artic 6, B1 / T 15, CE	66014929	FDA UDI	Class II	Active
Artic	66080472	FDA UDI	Class II	Active
Mondial 6, B1 / L341, CE	66017003	FDA UDI	Class II	Active
Basic 6, D2 / L05, CE	56739142	FDA UDI	Class II	Unknown
Basic 6, A2 / A11, CE	56739018	FDA UDI	Class II	Unknown
HC-Zirkonia Gingiva-Set	66055385	FDA UDI	Class II	Unknown

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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