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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 31 of 123

Device	Model / Reference	Registries	Class	Status
Artic digital 8, BL3 / 20 degrees-30LD, CE	66080801	FDA UDI	Class II	Active
Signum composite	66020035	FDA UDI	Class II	Active
Signum cre-active	66020052	FDA UDI	Class II	Active
Basic 6, D2 / L03, CE	56739110	FDA UDI	Class II	Unknown
Mondial 6i, D2 / L24, CE	66970809	FDA UDI	Class II	Active
Mondial 8i, A3 / XS, CE	66970870	FDA UDI	Class II	Active
Artic 6, B4 / L 15, CE	66014983	FDA UDI	Class II	Active
Premium 6, B4 / O2, CE	66006883	FDA UDI	Class II	Unknown
Artic 6, A1 / L 55, CE	66014858	FDA UDI	Class II	Active
Mondial 8, C1 / 33L, CE	66017386	FDA UDI	Class II	Active
Delara	66071187	FDA UDI	Class II	Active
Venus Pearl	66048180	FDA UDI	Class II	Active
Artic 6, A1 / R 30, CE	66014845	FDA UDI	Class II	Active
Premium 6, C2 / L12, CE	66006907	FDA UDI	Class II	Unknown
Delara	66071238	FDA UDI	Class II	Active
Mondial 8, BL1 / 35 U, CE	66801110	FDA UDI	Class II	Unknown
Basic 6, C2 / U03, CE	56739283	FDA UDI	Class II	Unknown
Basic 8, A3.5 / EU, CE	56739580	FDA UDI	Class II	Unknown
Delara	66071174	FDA UDI	Class II	Active
Artic digital 8, C3 / 10 degrees-30 UD, CE	66080746	FDA UDI	Class II	Active
Mondial 8, A4 / 33L, CE	66017336	FDA UDI	Class II	Active
Artic 8, A3.5 / 20 degree - 34 U, CE	66012962	FDA UDI	Class II	Active
Premium 6, B3 / L12, CE	66006904	FDA UDI	Class II	Unknown
Artic 8, C1 / 30 degree - 34 U, CE	66037053	FDA UDI	Class II	Active
Artic 6, D4 / S 35, CE	66015088	FDA UDI	Class II	Active
Mondial 8, BL2 / 37L, CE	66801123	FDA UDI	Class II	Active
Delara	66071387	FDA UDI	Class II	Active
Mondial 6, A2 / L341, CE	66016891	FDA UDI	Class II	Active
Artic 6, A4 / L 10, CE	66014073	FDA UDI	Class II	Active
Delara	66071583	FDA UDI	Class II	Active
Dima	66087415	FDA UDI	Class II	Active
Artic	66080672	FDA UDI	Class II	Active
Delara	66071681	FDA UDI	Class II	Active
Artic	66080722	FDA UDI	Class II	Active
Artic digital 6, A3.5 / O30D, CE	66983033	FDA UDI	Class II	Active
Artic digital 8, A4 / 20 degree-32LD, CE	66983212	FDA UDI	Class II	Active
Basic 6, A3 / U01, CE	56739243	FDA UDI	Class II	Unknown
Mixing Tip green 1:1 48	66001989	FDA UDI	Class I	Active
Artic digital 6, B4 / TO05D, CE	66080445	FDA UDI	Class II	Active
Mondial 6, A1 / L315, CE	66016860	FDA UDI	Class II	Active
Mondial 6 DS, A3 / R483, CE	66985651	FDA UDI	Class II	Unknown
Mondial 8, BL1 / 33L, CE	66801109	FDA UDI	Class II	Unknown
Mondial 6 DS, A1 / L384, CE	66985605	FDA UDI	Class II	Unknown
Premium 6, B2 / L16, CE	66006935	FDA UDI	Class II	Unknown
Artic digital 8, C1 / 20 degrees-30 UD, CE	66080730	FDA UDI	Class II	Active
Mondial 8, A3 / 28 U, CE	66802116	FDA UDI	Class II	Active
Mondial 8, BL3 / 30 U, CE	66802214	FDA UDI	Class II	Active
Artic 6, B4 / O 30, CE	66014971	FDA UDI	Class II	Active
Artic	66080274	FDA UDI	Class II	Active
Artic	66080436	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