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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 23 of 123

Device	Model / Reference	Registries	Class	Status
Artic digital 6, B4 / O30D, CE	66983088	FDA UDI	Class II	Active
Basic 6, D4 / U04, CE	56739304	FDA UDI	Class II	Unknown
HeraCeram Pastenopaker PO B3, 2ml	66003351	FDA UDI	Class II	Unknown
Mondial 8i, C4 / L, CE	66970972	FDA UDI	Class II	Active
Mondial 6 DS, A3.5 / L378, CE	66985711	FDA UDI	Class II	Unknown
Basic 8, B2 / DU, CE	56739487	FDA UDI	Class II	Unknown
Artic 6, B3 / L 25, CE	66014968	FDA UDI	Class II	Active
Delara	66071517	FDA UDI	Class II	Active
Artic digital 8, BL3 / 10 degrees-32 UD, CE	66080798	FDA UDI	Class II	Active
Mondial 6, B4 / T440, CE	66975579	FDA UDI	Class II	Active
Artic 6, A3.5 / L 10, CE	66012899	FDA UDI	Class II	Active
Artic digital 6, A4 / TO30D, CE	66080359	FDA UDI	Class II	Active
Delara	66071136	FDA UDI	Class II	Active
Basic 6, C4 / U07, CE	56739349	FDA UDI	Class II	Unknown
Mondial 8, A3 / 32L, CE	66802121	FDA UDI	Class II	Active
VENUS DIAMOND SYRINGE REFILL 1x4G OB	66035489	FDA UDI	Class II	Active
Artic digital 8, C1 / 10 degrees-32 UD, CE	66080728	FDA UDI	Class II	Active
Artic digital 8, A2 / 10 degrees-30LD, CE	66080647	FDA UDI	Class II	Active
Artic digital 6, D3 / O10D, CE	66080566	FDA UDI	Class II	Active
Mondial 8i, B4 / 37 U, CE	66973854	FDA UDI	Class II	Active
Mondial 8i, BL3 / 37L, CE	66973871	FDA UDI	Class II	Active
Mondial 6, A3.5 / L384, CE	66016953	FDA UDI	Class II	Active
Mondial 6, A2 / R449, CE	66016872	FDA UDI	Class II	Active
Artic digital 8, A1 / 20 degree-34 UD, CE	66983189	FDA UDI	Class II	Active
Mondial 6i, D2 / O4, CE	66970796	FDA UDI	Class II	Active
Flexitime Fast&Scan Dyn. Putty 2x380ml	66044882	FDA UDI	Class II	Unknown
Mondial 8, A4 / 29L, CE	66017332	FDA UDI	Class II	Active
Mondial 6, C3 / L331, CE	66017170	FDA UDI	Class II	Active
Delara	66071439	FDA UDI	Class II	Active
Artic digital 6, A3.5 / L05D, CE	66080339	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 1x10x0, 25G CO	66039029	FDA UDI	Class II	Active
Mondial 8, D2 / 28 U, CE	66802182	FDA UDI	Class II	Active
Artic digital 8, B3 / 10 degrees-30LD, CE	66080707	FDA UDI	Class II	Active
Mondial 6, B2 / L341, CE	66017031	FDA UDI	Class II	Active
Basic 6, C2 / A13, CE	56739059	FDA UDI	Class II	Unknown
Mondial 8i DS, A3 / 35L, CE	66986838	FDA UDI	Class II	Unknown
Delara	66071302	FDA UDI	Class II	Active
Mondial 8, C3 / 37L, CE	66017410	FDA UDI	Class II	Active
Artic 6, BL3 / O 20, CE	66970412	FDA UDI	Class II	Active
iBOND Total Etch Single Dose Refill	66040093	FDA UDI	Class II	Active
Basic 6, D4 / P22, CE	56739224	FDA UDI	Class II	Unknown
Basic 6, D2 / A13, CE	56739062	FDA UDI	Class II	Unknown
Mondial 6, B1 / L382, CE	66017008	FDA UDI	Class II	Active
Delara	66071229	FDA UDI	Class II	Active
Mondial 6, D4 / L341, CE	66017283	FDA UDI	Class II	Active
Mondial 6, A2 / T452, CE	66975524	FDA UDI	Class II	Active
Mondial 6, A1 / T450, CE	66016849	FDA UDI	Class II	Active
Venus Pearl	66048193	FDA UDI	Class II	Active
Premium 6, A3 / T2, CE	66007141	FDA UDI	Class II	Unknown
Mondial 6i DS, A2 / O6, CE	66986250	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