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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 63 of 123

Device	Model / Reference	Registries	Class	Status
Signum matrix	66019706	FDA UDI	Class II	Active
Mondial 6, C4 / L331, CE	66017198	FDA UDI	Class II	Active
Mondial 8i, A2 / XS, CE	66970862	FDA UDI	Class II	Active
Artic 8, C4 / 30 degree - 32 L, CE	66037070	FDA UDI	Class II	Active
PalaXpress ultra, clear, 1000g	66034255	FDA UDI	Class II	Unknown
VENUS Diamond FLOW	66100275	FDA UDI	Class II	Active
FLEXITIME DYNAMIX HT REFILL 1X(2X380ml)	60035992	FDA UDI	Class II	Unknown
Artic 6, D3 / O 10, CE	66014044	FDA UDI	Class II	Active
Artic digital 6, A3 / TO10D, CE	66080314	FDA UDI	Class II	Active
Delara	66071161	FDA UDI	Class II	Active
Artic 6, C3 / L 45, CE	66015033	FDA UDI	Class II	Active
Premium 6, A3.5 / O4, CE	66007014	FDA UDI	Class II	Unknown
Artic digital 6, A4 / T20D, CE	66080354	FDA UDI	Class II	Active
Delara	66071303	FDA UDI	Class II	Active
Artic 8, A2 / 0 degree - 32 L, CE	66015112	FDA UDI	Class II	Active
Artic 6, C1 / TO 20, CE	66014997	FDA UDI	Class II	Active
Mondial 8, B4 / 28 U, CE	66802152	FDA UDI	Class II	Active
Basic 6, B2 / U06, CE	56739327	FDA UDI	Class II	Unknown
Mondial 6, A4 / T515, CE	66016965	FDA UDI	Class II	Active
Artic 6, A3 / TO 30, CE	66012884	FDA UDI	Class II	Active
Delara	66071336	FDA UDI	Class II	Active
Artic 6, A1 / T 20, CE	66012847	FDA UDI	Class II	Active
Artic 6, A3.5 / T 40, CE	66012864	FDA UDI	Class II	Active
Delara	66071664	FDA UDI	Class II	Active
Premium 8, BL3 / SL, CE	66803003	FDA UDI	Class II	Unknown
Venus Pearl	66048100	FDA UDI	Class II	Active
HeraCeram Dentin DB1, 100g	66003377	FDA UDI	Class II	Unknown
Mondial 6i, A3.5 / L19, CE	66970542	FDA UDI	Class II	Active
Artic digital 8, A4 / 20 degree-36 UD, CE	66983215	FDA UDI	Class II	Active
Mondial 8i, D4 / 35 U, CE	66973924	FDA UDI	Class II	Active
PalaXpress ultra, pink , 1000g	66034252	FDA UDI	Class II	Unknown
Mondial 6, C1 / R449, CE	66017097	FDA UDI	Class II	Active
Artic 8, B2 / 10 degree - 30 U, CE	66015163	FDA UDI	Class II	Active
Premium 8, B3 / XSL, CE	66007306	FDA UDI	Class II	Unknown
Delara	66071455	FDA UDI	Class II	Active
Delara	66071293	FDA UDI	Class II	Active
Mondial 6, BL2 / L331, CE	66801039	FDA UDI	Class II	Active
Delara	66071634	FDA UDI	Class II	Active
Delara	66071256	FDA UDI	Class II	Active
Delara	66071175	FDA UDI	Class II	Active
Mondial 8, C2 / 29 U, CE	66017391	FDA UDI	Class II	Active
Mondial 6, B4 / L362, CE	66017088	FDA UDI	Class II	Active
Artic 6, A2 / O 20, CE	66012876	FDA UDI	Class II	Active
Venus Pearl	66098263	FDA UDI	Class II	Active
Basic 6, B3 / P22, CE	56739216	FDA UDI	Class II	Unknown
Premium 6, A3.5 / L14, CE	66006916	FDA UDI	Class II	Unknown
Flexitime Heavy Tray & Flow Trial Kit	66041063	FDA UDI	Class II	Active
Premium 8, A3 / LL, CE	66007205	FDA UDI	Class II	Unknown
Mondial 8i, B4 / XS, CE	66970918	FDA UDI	Class II	Active
Premium 8, A3.5 / M, CE	66007222	FDA UDI	Class II	Unknown

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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