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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 57 of 123

Device	Model / Reference	Registries	Class	Status
Premium 8, B4 / S, CE	66007259	FDA UDI	Class II	Unknown
Artic digital 8, B3 / 10 degrees-30 UD, CE	66080706	FDA UDI	Class II	Active
Mondial 6, C3 / T450, CE	66017158	FDA UDI	Class II	Active
Artic	66080645	FDA UDI	Class II	Active
Mondial 8i, A2 / 31 U, CE	66973792	FDA UDI	Class II	Active
Artic 6, C4 / L 20, CE	66014087	FDA UDI	Class II	Active
ST Basic 8, CE	66030385	FDA UDI	Class II	Active
Basic 8, A2 / DO, CE	56739466	FDA UDI	Class II	Unknown
Artic digital 8, BL3 / 20 degrees-30 UD, CE	66080800	FDA UDI	Class II	Active
Mondial 6, D4 / L331, CE	66017282	FDA UDI	Class II	Active
Delara	66071309	FDA UDI	Class II	Active
Artic 8, C3 / 30 degree - 32 U, CE	66037063	FDA UDI	Class II	Active
Charisma	66000094	FDA UDI	Class II	Active
Basic 8, C3 / HU, CE	56739556	FDA UDI	Class II	Unknown
Mondial 6, B2 / L315, CE	66017029	FDA UDI	Class II	Active
Mondial 6i, B4 / L20, CE	66970653	FDA UDI	Class II	Active
Mondial 6i, BL2 / T4, CE	66970661	FDA UDI	Class II	Active
Mondial 6i, C2 / L22, CE	66970742	FDA UDI	Class II	Active
Basic 8, A3 / CO, CE	56739435	FDA UDI	Class II	Unknown
Mondial 6, C1 / L369, CE	66017117	FDA UDI	Class II	Active
Dispensing Gun 2 (1:1/2:1)	66001970	FDA UDI	Class I	Active
Premium 6, D4 / T2, CE	66007154	FDA UDI	Class II	Unknown
Artic 8, D4 / 10 degree - 30 L, CE	66015254	FDA UDI	Class II	Active
Basic 8, C4 / FO, CE	56739605	FDA UDI	Class II	Unknown
Artic 8, B4 / 20 degree - 36 U, CE	66015187	FDA UDI	Class II	Active
Artic 8, C4 / 20 degree - 36 L, CE	66015228	FDA UDI	Class II	Active
Artic 6, BL3 / T 20, CE	66970408	FDA UDI	Class II	Active
Gluma Desensitizer Value Pack 3 X 5 Ml	66018221	FDA UDI	Class II	Active
Mondial 8, A3.5 / 37L, CE	66017330	FDA UDI	Class II	Active
Artic 6, A3.5 / TO 10, CE	66014900	FDA UDI	Class II	Active
Mondial 6i, A3 / T2, CE	66970506	FDA UDI	Class II	Active
Artic digital 6, A1 / T30D, CE	66983006	FDA UDI	Class II	Active
Artic digital 6, A3 / R20D, CE	66983023	FDA UDI	Class II	Active
Mondial 6, C4 / L398, CE	66017206	FDA UDI	Class II	Active
Mondial 6i, B3 / O4, CE	66970620	FDA UDI	Class II	Active
Artic digital 6, A2 / R30D, CE	66983013	FDA UDI	Class II	Active
Artic digital 6, A3 / L20D, CE	66983030	FDA UDI	Class II	Active
Artic 8, A3 / 0 degree - 32 U, CE	66015121	FDA UDI	Class II	Active
Premium 6, C2 / O4, CE	66007021	FDA UDI	Class II	Unknown
Mondial 6i DS, A3.5 / R8, CE	66986288	FDA UDI	Class II	Unknown
Flexitime Mono Phase 1 X (2 X 50 Ml)	66002200	FDA UDI	Class II	Active
Mondial 8, D4 / 32 U, CE	66802198	FDA UDI	Class II	Active
Artic digital 6, D2 / L05D, CE	66080559	FDA UDI	Class II	Active
Mondial 8i, BL3 / 35 U, CE	66973868	FDA UDI	Class II	Active
Artic digital 6, B3 / R30D, CE	66983079	FDA UDI	Class II	Active
Venus Pearl	66096878	FDA UDI	Class II	Active
Mondial 6i DS, B1 / O2, CE	66986336	FDA UDI	Class II	Unknown
Mondial 8i, BL2 / 37 U, CE	66973862	FDA UDI	Class II	Active
Basic 8, A4 / HU, CE	56739549	FDA UDI	Class II	Unknown
Mondial 6, D2 / T495, CE	66975637	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