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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 80 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 6i, A3 / L24, CE	66970523	FDA UDI	Class II	Active
Mondial 8i, B2 / 31 U, CE	66973832	FDA UDI	Class II	Active
Mondial 8, A3.5 / 29 U, CE	66017321	FDA UDI	Class II	Active
Artic 8, B1 / 0 degree - 30 L, CE	66015150	FDA UDI	Class II	Active
Artic digital 6, A2 / O10D, CE	66080280	FDA UDI	Class II	Active
Artic digital 6, C1 / R20D, CE	66983111	FDA UDI	Class II	Active
Mondial 6, B1 / L362, CE	66017004	FDA UDI	Class II	Active
Premium 8, A2 / M, CE	66007220	FDA UDI	Class II	Unknown
Mondial 6, A3.5 / T452, CE	66975540	FDA UDI	Class II	Active
Artic 6, BL3 / L 10, CE	66970415	FDA UDI	Class II	Active
Mondial 6i DS, B1 / R4, CE	66986330	FDA UDI	Class II	Unknown
Artic 6, BL3 / L 15, CE	66970432	FDA UDI	Class II	Active
Mondial 6, C1 / S451, CE	66975599	FDA UDI	Class II	Active
Basic 8, A2 / HO, CE	56739530	FDA UDI	Class II	Unknown
Mondial 8i, A1 / 33L, CE	66973787	FDA UDI	Class II	Active
Delara	66071568	FDA UDI	Class II	Active
Artic	66080510	FDA UDI	Class II	Active
Mondial 6, BL1 / R449, CE	66800998	FDA UDI	Class II	Unknown
Mondial 6, A4 / L378, CE	66016979	FDA UDI	Class II	Active
Mondial 6, A2 / L398, CE	66016898	FDA UDI	Class II	Active
Mondial 8i, D2 / 35L, CE	66973909	FDA UDI	Class II	Active
Premium 6, C1 / O4, CE	66007020	FDA UDI	Class II	Unknown
Mondial 8i, B3 / XS, CE	66970910	FDA UDI	Class II	Active
HC-Zirkonia Schneide S4, 20g	66020207	FDA UDI	Class II	Unknown
Artic digital 8, A2 / 20 degree-36 UD, CE	66983197	FDA UDI	Class II	Active
Mondial 8i, C1 / 35L, CE	66973877	FDA UDI	Class II	Active
Artic 8, C3 / 0 degree - 30 L, CE	66015210	FDA UDI	Class II	Active
Mondial 8i, D4 / XSL, CE	66970991	FDA UDI	Class II	Active
Mondial 6i DS, A3 / L22, CE	66986283	FDA UDI	Class II	Unknown
Mondial 6 DS, A2 / L341, CE	66985635	FDA UDI	Class II	Unknown
Dima	66077051	FDA UDI	Class II	Unknown
VENUS FLOW SYR 1 x 1, 8G - B3	66014569	FDA UDI	Class II	Active
Mondial 8 DS, A1 / 31L, CE	66986618	FDA UDI	Class II	Unknown
Mondial 6, A3.5 / O457, CE	66016939	FDA UDI	Class II	Active
Delara	66071637	FDA UDI	Class II	Active
Mondial 8i, C3 / L, CE	66970964	FDA UDI	Class II	Active
Delara	66071445	FDA UDI	Class II	Active
Delara	66071607	FDA UDI	Class II	Active
VENUS DIAMOND SYRINGE REFILL 1x4G C2	66035481	FDA UDI	Class II	Active
Mondial 8i, A4 / 31 U, CE	66973816	FDA UDI	Class II	Active
Delara	66071493	FDA UDI	Class II	Active
Artic	66080632	FDA UDI	Class II	Active
Artic	66080663	FDA UDI	Class II	Active
Artic digital 6, B3 / TO40D, CE	66080426	FDA UDI	Class II	Active
Venus Pearl Samples	66054263	FDA UDI	Class II	Unknown
VENUS DIAMOND SYRINGE REFILL 1x4G A1	66035471	FDA UDI	Class II	Active
Mondial 8, D2 / 30 U, CE	66802184	FDA UDI	Class II	Active
Artic digital 8, C4 / 20 degrees-30LD, CE	66080761	FDA UDI	Class II	Active
Mondial 8i, B3 / 35 U, CE	66973844	FDA UDI	Class II	Active
Mondial 8, BL2 / 32L, CE	66802211	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