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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 69 of 123

Device	Model / Reference	Registries	Class	Status
Artic	66080482	FDA UDI	Class II	Active
Mondial 6, BL3 / S445, CE	66801058	FDA UDI	Class II	Active
Premium 6, A1 / L22, CE	66006977	FDA UDI	Class II	Unknown
Artic 8, C2 / 0 degree - 30 U, CE	66015199	FDA UDI	Class II	Active
Premium 6, A3 / S6, CE	66007125	FDA UDI	Class II	Unknown
Charisma ABC	66064797	FDA UDI	Class II	Active
Mondial 6, D3 / L373, CE	66017258	FDA UDI	Class II	Active
Mondial 8i, C2 / 35L, CE	66973885	FDA UDI	Class II	Active
VENUS DIAMOND SYRINGE REFILL 1x4G B2	66035479	FDA UDI	Class II	Active
Artic 6, B4 / L 55, CE	66014986	FDA UDI	Class II	Active
Artic	66080755	FDA UDI	Class II	Active
Artic	66080674	FDA UDI	Class II	Active
Mondial 6, BL2 / T465, CE	66801035	FDA UDI	Class II	Active
Delara	66071558	FDA UDI	Class II	Active
Mondial 6, A4 / O457, CE	66016967	FDA UDI	Class II	Active
Delara	66071656	FDA UDI	Class II	Active
Artic 8, A3 / 20 degree - 32 L, CE	66012954	FDA UDI	Class II	Active
Artic digital 8, D4 / 20 degree-36LD, CE	66983288	FDA UDI	Class II	Active
Mondial 6, A3 / S550, CE	66975529	FDA UDI	Class II	Active
Mondial 6i, B3 / S2, CE	66970622	FDA UDI	Class II	Active
Mondial 6i, A1 / R6, CE	66970460	FDA UDI	Class II	Active
Venus Diamond	66096868	FDA UDI	Class II	Active
Artic digital 6, A3 / L55D, CE	66983032	FDA UDI	Class II	Active
Artic digital 8, D2 / 20 degree-32LD, CE	66983272	FDA UDI	Class II	Active
Mondial 8, BL2 / 32 U, CE	66802210	FDA UDI	Class II	Active
Mondial 6, B3 / R455, CE	66017042	FDA UDI	Class II	Active
Delara	66071225	FDA UDI	Class II	Active
Mondial 6, D2 / O525, CE	66017221	FDA UDI	Class II	Active
Mondial 6i DS, A3 / O6, CE	66986272	FDA UDI	Class II	Unknown
Mondial 6 DS, A3.5 / L315, CE	66985705	FDA UDI	Class II	Unknown
Provil Novo P Reg 1x500	50035414	FDA UDI	Class II	Unknown
Artic 6, D2 / T 35, CE	66015058	FDA UDI	Class II	Active
Artic digital 6, BL3 / TO40D, CE	66080624	FDA UDI	Class II	Active
Mondial 6, BL3 / R455, CE	66801055	FDA UDI	Class II	Active
Artic 6, BL3 / TO 20, CE	66970430	FDA UDI	Class II	Active
Artic digital 6, A1 / L05D, CE	66080273	FDA UDI	Class II	Active
Mondial 8, C3 / 31L, CE	66017404	FDA UDI	Class II	Active
Artic 8, BL3 / 30 degree - 32 U, CE	66970454	FDA UDI	Class II	Active
Basic 8, A3.5 / FO, CE	56739596	FDA UDI	Class II	Unknown
Mondial 6, BL3 / T515, CE	66801065	FDA UDI	Class II	Active
Signum composite flow	66049061	FDA UDI	Class II	Active
Mondial 8, B1 / 28L, CE	66802135	FDA UDI	Class II	Active
Premium 6, BL3 / L20, CE	66802964	FDA UDI	Class II	Unknown
Premium 6, B4 / S4, CE	66007115	FDA UDI	Class II	Unknown
Premium 6, B3 / O6, CE	66007034	FDA UDI	Class II	Unknown
Premium 8, C3 / M, CE	66007230	FDA UDI	Class II	Unknown
Artic digital 6, D4 / S40D, CE	66983181	FDA UDI	Class II	Active
Mondial 8i DS, A1 / 37L, CE	66986808	FDA UDI	Class II	Unknown
Mondial 6 DS, B1 / T452, CE	66985772	FDA UDI	Class II	Unknown
Mondial 6, A3 / R520, CE	66975526	FDA UDI	Class II	Active

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Authorities

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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