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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 38 of 123

Device	Model / Reference	Registries	Class	Status
Artic 6, A4 / S 20, CE	66013974	FDA UDI	Class II	Active
Artic 8, C2 / 10 degree - 32 L, CE	66015206	FDA UDI	Class II	Active
Charisma	66000113	FDA UDI	Class II	Active
Artic 6, B1 / R 40, CE	66014926	FDA UDI	Class II	Active
HC-Zirkonia Schneide Bleach S BL, 20 g.	66021891	FDA UDI	Class II	Unknown
Artic 6, B4 / S 20, CE	66013976	FDA UDI	Class II	Active
Premium 8, A3 / M, CE	66007221	FDA UDI	Class II	Unknown
Basic 6, A3 / A11, CE	56739019	FDA UDI	Class II	Unknown
Basic 6, A4 / L04, CE	56739117	FDA UDI	Class II	Unknown
Artic	66080408	FDA UDI	Class II	Active
Artic digital 8, D3 / 20 degree-36LD, CE	66983282	FDA UDI	Class II	Active
Delara	66071630	FDA UDI	Class II	Active
Mondial 6, A3 / O525, CE	66016913	FDA UDI	Class II	Active
Artic digital 6, A4 / T15D, CE	66080353	FDA UDI	Class II	Active
Delara	66071218	FDA UDI	Class II	Active
Mondial 8, B2 / 31 U, CE	66017353	FDA UDI	Class II	Active
Delara	66071603	FDA UDI	Class II	Active
Mondial 8, A2 / 32 U, CE	66802114	FDA UDI	Class II	Active
Artic digital 8, A4 / 10 degrees-32 UD, CE	66080678	FDA UDI	Class II	Active
Signum composite flow	66048944	FDA UDI	Class II	Active
Mondial 6, A4 / O525, CE	66016969	FDA UDI	Class II	Active
Artic 6, A4 / T 15, CE	66014913	FDA UDI	Class II	Active
Delara	66071144	FDA UDI	Class II	Active
Mondial 6, C1 / S443, CE	66017110	FDA UDI	Class II	Active
Mondial 6, D3 / S451, CE	66975639	FDA UDI	Class II	Active
Mondial 6, B2 / R520, CE	66975558	FDA UDI	Class II	Active
Mondial 8i DS, A3.5 / 35 U, CE	66986853	FDA UDI	Class II	Unknown
Mondial 6, A4 / O510, CE	66016968	FDA UDI	Class II	Active
Mondial 6, A1 / T452, CE	66975516	FDA UDI	Class II	Active
Dima	66087420	FDA UDI	Class II	Active
Artic	66080587	FDA UDI	Class II	Active
Mondial 6i, C4 / O4, CE	66970774	FDA UDI	Class II	Active
Mondial 8, D3 / 28 U, CE	66802188	FDA UDI	Class II	Active
Flexitime Bite Cartridge Refill1(2x50ml)	50066038	FDA UDI	Class II	Active
Signum matrix	66019701	FDA UDI	Class II	Active
Artic 6, C1 / L 50, CE	66014112	FDA UDI	Class II	Active
Mondial 8i, A2 / S, CE	66970864	FDA UDI	Class II	Active
Mondial 8i, C3 / M, CE	66970962	FDA UDI	Class II	Active
Mondial 6 DS, B1 / O525, CE	66985754	FDA UDI	Class II	Unknown
Mondial 6, B3 / S502, CE	66975568	FDA UDI	Class II	Active
Mondial 8, A2 / 30 U, CE	66802112	FDA UDI	Class II	Active
Mondial 6, BL2 / T405, CE	66801032	FDA UDI	Class II	Active
Mondial 6i, B4 / S8, CE	66970647	FDA UDI	Class II	Active
Mondial 8, BL1 / 28 U, CE	66802200	FDA UDI	Class II	Unknown
Mondial 6, A3.5 / T515, CE	66016937	FDA UDI	Class II	Active
Mondial 6, A2 / R455, CE	66016873	FDA UDI	Class II	Active
Basic 6, A2 / A10, CE	56739002	FDA UDI	Class II	Unknown
Delara	66071646	FDA UDI	Class II	Active
Delara	66071663	FDA UDI	Class II	Active
Mondial 6i, B3 / T2, CE	66970616	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