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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 33 of 123

Device	Model / Reference	Registries	Class	Status
Artic digital 6, B2 / L55D, CE	66983076	FDA UDI	Class II	Active
Mondial 8i, D4 / 31 U, CE	66973920	FDA UDI	Class II	Active
Artic digital 6, B4 / S40D, CE	66983093	FDA UDI	Class II	Active
Mondial 6i, A2 / T2, CE	66970484	FDA UDI	Class II	Active
Mondial 6, C3 / L373, CE	66017174	FDA UDI	Class II	Active
Artic, Sample Pack	66015635	FDA UDI	Class II	Active
Delara	66071384	FDA UDI	Class II	Active
Artic digital 6, C4 / L05D, CE	66080537	FDA UDI	Class II	Active
Mondial 6, D4 / S445, CE	66017279	FDA UDI	Class II	Active
Artic digital 8, C3 / 20 degree-32 UD, CE	66983259	FDA UDI	Class II	Active
Mondial 8i, C4 / 31 U, CE	66973896	FDA UDI	Class II	Active
Mondial 6i, C4 / O6, CE	66970775	FDA UDI	Class II	Active
Mondial 6, BL3 / T435, CE	66975594	FDA UDI	Class II	Active
Premium 6, A2 / O2, CE	66006995	FDA UDI	Class II	Unknown
Mondial 8 DS, A3 / 37L, CE	66986644	FDA UDI	Class II	Unknown
Mondial 6, C3 / S453, CE	66017168	FDA UDI	Class II	Active
Basic 6, A3.5 / P22, CE	56739212	FDA UDI	Class II	Unknown
Mondial 6i, BL3 / L20, CE	66970697	FDA UDI	Class II	Active
Signum composite	66020009	FDA UDI	Class II	Active
Signum composite	66020016	FDA UDI	Class II	Active
Artic digital 6, C1 / TO40D, CE	66080470	FDA UDI	Class II	Active
Artic	66080723	FDA UDI	Class II	Active
Venus Diamond	66098264	FDA UDI	Class II	Active
Basic 8, A4 / CU, CE	56739453	FDA UDI	Class II	Unknown
Mondial 6, B2 / R455, CE	66017014	FDA UDI	Class II	Active
Basic 6, A3.5 / U01, CE	56739244	FDA UDI	Class II	Unknown
Mondial 6i, A3 / L12, CE	66970516	FDA UDI	Class II	Active
Basic 6, A4 / U02, CE	56739261	FDA UDI	Class II	Unknown
Artic 6, B4 / TO 30, CE	66014057	FDA UDI	Class II	Active
Sopira Citoject Barr Str 1.8ml/Inch La	66002393	FDA UDI	Class II	Active
Artic 8, A3 / 20 degree - 36 U, CE	66015127	FDA UDI	Class II	Active
Artic 8, B3 / 20 degree - 34 U, CE	66014155	FDA UDI	Class II	Active
Artic 8, C4 / 10 degree - 32 U, CE	66015225	FDA UDI	Class II	Active
Artic 8, A4 / 10 degree - 30 L, CE	66015144	FDA UDI	Class II	Active
Artic 6, D3 / T 15, CE	66015073	FDA UDI	Class II	Active
Artic 8, D2 / 10 degree - 32 U, CE	66015235	FDA UDI	Class II	Active
Mondial 6, B2 / L373, CE	66017034	FDA UDI	Class II	Active
Artic 8, B3 / 0 degree - 32 U, CE	66015171	FDA UDI	Class II	Active
Artic 6, D4 / T 35, CE	66015090	FDA UDI	Class II	Active
Flexitime Monophase Bulk Pack 50x50ml	66067665	FDA UDI	Class II	Active
Mondial 6i, C4 / S4, CE	66970777	FDA UDI	Class II	Active
Delara	66071366	FDA UDI	Class II	Active
Mondial 6, BL3 / O444, CE	66801048	FDA UDI	Class II	Active
Artic digital 6, B2 / O20D, CE	66080391	FDA UDI	Class II	Active
Basic 6, B2 / L04, CE	56739119	FDA UDI	Class II	Unknown
Basic 6, C3 / U07, CE	56739348	FDA UDI	Class II	Unknown
Basic 6, D3 / L02, CE	56739095	FDA UDI	Class II	Unknown
Artic	66080406	FDA UDI	Class II	Active
Mondial 6i, B3 / T4, CE	66970617	FDA UDI	Class II	Active
IBOND UNIVERSAL BOTTLE VALUE PACK 3x4ml	66061412	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