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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 67 of 123

Device	Model / Reference	Registries	Class	Status
Artic 6, A3 / R 40, CE	66014878	FDA UDI	Class II	Active
Mondial 8i, D3 / M, CE	66970986	FDA UDI	Class II	Active
FLEXITIME DYNAMIX PUTTY REFILL1X(2X380ml	40003992	FDA UDI	Class II	Active
Basic 6, B1 / L06, CE	56739150	FDA UDI	Class II	Unknown
Artic 6, B4 / S 40, CE	66013994	FDA UDI	Class II	Active
Premium 6, A3 / L18, CE	66006947	FDA UDI	Class II	Unknown
HeraCeram Opaker OB2, 20g	66003312	FDA UDI	Class II	Unknown
Mondial 6 DS, A3.5 / L362, CE	66985708	FDA UDI	Class II	Unknown
Paladon 65, R 50 veined, 1000 g	64707711	FDA UDI	Class II	Active
Artic 6, B4 / R 30, CE	66014973	FDA UDI	Class II	Active
Mondial 6, A3 / L315, CE	66016917	FDA UDI	Class II	Active
Artic	66080276	FDA UDI	Class II	Active
Dima	66077056	FDA UDI	Class II	Active
dima	66075560	FDA UDI	Class II	Active
Artic 6, A3 / O 30, CE	66014875	FDA UDI	Class II	Active
Artic	66080715	FDA UDI	Class II	Active
Artic 6, A3.5 / S 05, CE	66014895	FDA UDI	Class II	Active
Artic digital 6, B4 / TO40D, CE	66080448	FDA UDI	Class II	Active
Artic	66080286	FDA UDI	Class II	Active
Delara	66071295	FDA UDI	Class II	Active
Mondial 6, C1 / S453, CE	66017112	FDA UDI	Class II	Active
Mondial 8, A4 / 28 U, CE	66802128	FDA UDI	Class II	Active
Basic 8, C4 / BO, CE	56739413	FDA UDI	Class II	Unknown
Basic 8, D2 / BU, CE	56739430	FDA UDI	Class II	Unknown
Kulzer	66019748	FDA UDI	Class I	Active
Artic	66080793	FDA UDI	Class II	Active
Basic 6, B1 / P22, CE	56739214	FDA UDI	Class II	Unknown
Basic 6, B4 / A11, CE	56739025	FDA UDI	Class II	Unknown
Basic 6, A3 / A10, CE	56739003	FDA UDI	Class II	Unknown
Basic 6, A4 / L03, CE	56739101	FDA UDI	Class II	Unknown
Artic	66080682	FDA UDI	Class II	Active
HC-Zirkonia Opal Schn. Bleach OS BL, 20g	66021892	FDA UDI	Class II	Unknown
Artic 6, C3 / S 30, CE	66013987	FDA UDI	Class II	Active
Basic 6, B3 / L05, CE	56739136	FDA UDI	Class II	Unknown
Basic 6, C1 / P23, CE	56739234	FDA UDI	Class II	Unknown
Premium 8, A1 / XSL, CE	66007299	FDA UDI	Class II	Unknown
Artic	66080439	FDA UDI	Class II	Active
Mondial 6, A3.5 / T465, CE	66016935	FDA UDI	Class II	Active
Signum composite	66020013	FDA UDI	Class II	Active
VENUS DIAMOND SYRINGE REFILL 1x4G A3	66035474	FDA UDI	Class II	Active
Artic digital 6, C1 / T35D, CE	66080465	FDA UDI	Class II	Active
Mondial 6, A2 / T477, CE	66016880	FDA UDI	Class II	Active
Mondial 6i, B1 / L24, CE	66970589	FDA UDI	Class II	Active
Delara	66071349	FDA UDI	Class II	Active
Artic digital 8, C4 / 20 degree-34LD, CE	66983268	FDA UDI	Class II	Active
Delara	66071626	FDA UDI	Class II	Active
Delara	66071464	FDA UDI	Class II	Active
Basic 8, A1 / EU, CE	56739577	FDA UDI	Class II	Unknown
Mondial 8i, A3 / SL, CE	66970873	FDA UDI	Class II	Active
Mondial 6i, D2 / T2, CE	66970792	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