Is this your brand? Sign in to claim ownership.

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 62 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8i, B2 / 33 U, CE	66973834	FDA UDI	Class II	Active
Basic 8, A2 / FU, CE	56739610	FDA UDI	Class II	Unknown
Artic 8, A1 / 30 degree - 32 U, CE	66036997	FDA UDI	Class II	Active
Artic 6, A4 / TO 40, CE	66014064	FDA UDI	Class II	Active
Mondial 6 DS, A2 / L315, CE	66985633	FDA UDI	Class II	Unknown
Mondial 8i, A1 / XS, CE	66970854	FDA UDI	Class II	Active
Artic 6, D3 / R 40, CE	66015070	FDA UDI	Class II	Active
Premium 6, B4 / R2, CE	66007051	FDA UDI	Class II	Unknown
Mondial 6, B4 / O457, CE	66017079	FDA UDI	Class II	Active
Mondial 8, D3 / 35 U, CE	66017437	FDA UDI	Class II	Active
Mondial 6, D4 / O457, CE	66017275	FDA UDI	Class II	Active
Basic 8, B3 / DU, CE	56739488	FDA UDI	Class II	Unknown
Basic 6, C1 / A11, CE	56739026	FDA UDI	Class II	Unknown
Mondial 8i, A3 / S, CE	66970872	FDA UDI	Class II	Active
Basic 6, C3 / L04, CE	56739124	FDA UDI	Class II	Unknown
Mondial 6i DS, A1 / T6, CE	66986225	FDA UDI	Class II	Unknown
Delara	66071417	FDA UDI	Class II	Active
Mondial 8, C4 / 35 U, CE	66017417	FDA UDI	Class II	Active
Artic	66080415	FDA UDI	Class II	Active
Mondial 6, D3 / T477, CE	66017244	FDA UDI	Class II	Active
Mondial 8, C3 / 33L, CE	66017406	FDA UDI	Class II	Active
Mondial 6, B4 / S443, CE	66017082	FDA UDI	Class II	Active
Artic 8, B1 / 30 degree - 30 U, CE	66037025	FDA UDI	Class II	Active
Delara	66071235	FDA UDI	Class II	Active
Artic	66080611	FDA UDI	Class II	Active
Venus Pearl Plt Basic Kit	66048211	FDA UDI	Class II	Unknown
Mondial 6, C3 / O510, CE	66017164	FDA UDI	Class II	Active
Artic digital 6, A1 / L25D, CE	66983009	FDA UDI	Class II	Active
Mondial 6i, A3.5 / S4, CE	66970535	FDA UDI	Class II	Active
Delara	66071420	FDA UDI	Class II	Active
Mondial 6 DS, A1 / S453, CE	66985584	FDA UDI	Class II	Unknown
Basic 8, A3.5 / BO, CE	56739404	FDA UDI	Class II	Unknown
Mondial 6i, A3.5 / L14, CE	66970539	FDA UDI	Class II	Active
Signum Opaque F	66020070	FDA UDI	Class II	Active
Premium 8, A4 / ML, CE	66007239	FDA UDI	Class II	Unknown
Premium 6, A3.5 / T4, CE	66007158	FDA UDI	Class II	Unknown
Mondial 6, C3 / O525, CE	66017165	FDA UDI	Class II	Active
Basic 8, C3 / FO, CE	56739604	FDA UDI	Class II	Unknown
Artic digital 6, B1 / L25D, CE	66983064	FDA UDI	Class II	Active
Mondial 6i, D4 / L19, CE	66970850	FDA UDI	Class II	Active
Artic 8, A2 / 20 degree - 34 U, CE	66012960	FDA UDI	Class II	Active
Mondial 8, C4 / 33 U, CE	66017415	FDA UDI	Class II	Active
Artic 6, A4 / L 45, CE	66014921	FDA UDI	Class II	Active
Delara	66071314	FDA UDI	Class II	Active
Mondial 8i, C1 / M, CE	66970946	FDA UDI	Class II	Active
Mondial 6i, A2 / O2, CE	66970487	FDA UDI	Class II	Active
Mondial 8, C2 / 30 U, CE	66802166	FDA UDI	Class II	Active
Artic digital 6, A4 / TO20D, CE	66983051	FDA UDI	Class II	Active
Mondial 6, C4 / L378, CE	66017203	FDA UDI	Class II	Active
Delara	66071546	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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