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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 58 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 6, B1 / T452, CE	66975556	FDA UDI	Class II	Active
Artic 8, C2 / 20 degree - 34 L, CE	66012972	FDA UDI	Class II	Active
Artic 6, A4 / TO 10, CE	66014916	FDA UDI	Class II	Active
Delara	66071149	FDA UDI	Class II	Active
Artic 6, A1 / L 05, CE	66014854	FDA UDI	Class II	Active
Artic digital 6, B2 / R30D, CE	66983068	FDA UDI	Class II	Active
Artic digital 8, B2 / 20 degree-34 UD, CE	66983225	FDA UDI	Class II	Active
Artic digital 6, D2 / TO20D, CE	66983161	FDA UDI	Class II	Active
Artic digital 6, B3 / R40D, CE	66983080	FDA UDI	Class II	Active
Artic	66080301	FDA UDI	Class II	Active
Mondial 8i, A3.5 / 33L, CE	66973811	FDA UDI	Class II	Active
Artic 6, A1 / S 20, CE	66012819	FDA UDI	Class II	Active
Premium 6, C2 / T2, CE	66007149	FDA UDI	Class II	Unknown
Premium 6, B3 / S4, CE	66007114	FDA UDI	Class II	Unknown
Mondial 6i DS, A1 / R6, CE	66986221	FDA UDI	Class II	Unknown
Mondial 6 DS, A3 / T435, CE	66985660	FDA UDI	Class II	Unknown
Artic 8, BL3 / 20 degree - 30 U, CE	66970436	FDA UDI	Class II	Active
Mondial 8i, A2 / 35L, CE	66973797	FDA UDI	Class II	Active
Mondial 6, B2 / R410, CE	66017011	FDA UDI	Class II	Active
Mondial 6i, A3.5 / S2, CE	66970534	FDA UDI	Class II	Active
Artic digital 6, A3 / R40D, CE	66983025	FDA UDI	Class II	Active
Mondial 6, BL2 / R483, CE	66801028	FDA UDI	Class II	Active
Artic	66080614	FDA UDI	Class II	Active
Artic	66080290	FDA UDI	Class II	Active
Mondial 6, D3 / T405, CE	66017240	FDA UDI	Class II	Active
Mondial 8, BL3 / 32 U, CE	66802216	FDA UDI	Class II	Active
Artic 6, D4 / O 20, CE	66014054	FDA UDI	Class II	Active
Artic digital 6, D2 / L55D, CE	66983164	FDA UDI	Class II	Active
Artic 8, C2 / 10 degree - 32 U, CE	66015205	FDA UDI	Class II	Active
Mondial 6, C1 / S550, CE	66975601	FDA UDI	Class II	Active
Artic 8, C4 / 0 degree - 32 L, CE	66015222	FDA UDI	Class II	Active
Premium 8, A1 / LL, CE	66007203	FDA UDI	Class II	Unknown
Artic 6, D2 / T 40, CE	66014034	FDA UDI	Class II	Active
Mondial 6 DS, A1 / R483, CE	66985579	FDA UDI	Class II	Unknown
Basic 6, C4 / U02, CE	56739269	FDA UDI	Class II	Unknown
Mondial 6i, A3.5 / T6, CE	66970530	FDA UDI	Class II	Active
Artic 6, A4 / L 25, CE	66014920	FDA UDI	Class II	Active
Basic 8, C4 / CO, CE	56739445	FDA UDI	Class II	Unknown
Premium 8, B1 / LL, CE	66007208	FDA UDI	Class II	Unknown
Mondial 6, A3.5 / L341, CE	66016947	FDA UDI	Class II	Active
Premium 6, B2 / L22, CE	66006984	FDA UDI	Class II	Unknown
Premium 8, B2 / M, CE	66007225	FDA UDI	Class II	Unknown
Mondial 6, C4 / L384, CE	66017205	FDA UDI	Class II	Active
Flexitime Correct Flow 1 X (2 X 50 Ml)	50034806	FDA UDI	Class II	Active
Mondial 6, A2 / O457, CE	66016883	FDA UDI	Class II	Active
Mondial 6, C4 / T440, CE	66975627	FDA UDI	Class II	Active
Mondial 8, C2 / 28L, CE	66802165	FDA UDI	Class II	Active
Premium 6, C3 / O4, CE	66007022	FDA UDI	Class II	Unknown
Delara	66071598	FDA UDI	Class II	Active
Signum matrix	66019694	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