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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 81 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8i, C3 / 37 U, CE	66973894	FDA UDI	Class II	Active
Mondial 6, D4 / S550, CE	66975649	FDA UDI	Class II	Active
Mondial 8i, BL3 / 33L, CE	66973867	FDA UDI	Class II	Active
Mondial 6, A4 / L315, CE	66016973	FDA UDI	Class II	Active
Delara	66071199	FDA UDI	Class II	Active
Mondial 6, A1 / T442, CE	66016848	FDA UDI	Class II	Active
Artic 6, B4 / L 45, CE	66014985	FDA UDI	Class II	Active
Premium 6, B1 / L20, CE	66006966	FDA UDI	Class II	Unknown
Cuttersil P Plus 1x900 Ml	65767038	FDA UDI	Class II	Active
Artic digital 8, B3 / 20 degree-36 UD, CE	66983233	FDA UDI	Class II	Active
Artic digital 6, C4 / L25D, CE	66983152	FDA UDI	Class II	Active
Mondial 6i DS, A1 / R8, CE	66986222	FDA UDI	Class II	Unknown
Premium 6, A4 / R2, CE	66007047	FDA UDI	Class II	Unknown
Basic 8, A1 / GO, CE	56739497	FDA UDI	Class II	Unknown
Provil Novo Mono F Cd 2 1x(2x50ml)	66008293	FDA UDI	Class II	Unknown
Mondial 6i, B2 / T2, CE	66970594	FDA UDI	Class II	Active
Mondial 6, A1 / O510, CE	66016855	FDA UDI	Class II	Active
Mondial 6, BL2 / T515, CE	66801037	FDA UDI	Class II	Active
VENUS Diamond FLOW PLT 20x0.20g - A3.5	66040372	FDA UDI	Class II	Active
Artic 6, C2 / L 50, CE	66012930	FDA UDI	Class II	Active
Mondial 6i, A3 / L19, CE	66970520	FDA UDI	Class II	Active
Mondial living Mould Chart A1	40003401	FDA UDI	Class II	Active
Mondial 6i, B1 / O2, CE	66970575	FDA UDI	Class II	Active
HeraCeram Opalschneide OS1, 20g	66003460	FDA UDI	Class II	Unknown
Basic 8, A3.5 / FU, CE	56739612	FDA UDI	Class II	Unknown
Basic 8, A3 / HO, CE	56739531	FDA UDI	Class II	Unknown
Basic 8, A2 / HU, CE	56739546	FDA UDI	Class II	Unknown
Artic digital 8, B2 / 10 degrees-30LD, CE	66080697	FDA UDI	Class II	Active
Venus Diamond	66081848	FDA UDI	Class II	Active
Artic 8, A3 / 0 degree - 30 U, CE	66015119	FDA UDI	Class II	Active
IOT yellow 96	66000782	FDA UDI	Class I	Active
Mondial 8 DS, A2 / 33 U, CE	66986629	FDA UDI	Class II	Unknown
HeraCeram Pastenopaker PO A3, 5, 2ml	66003347	FDA UDI	Class II	Unknown
Artic 8, D2 / 10 degree - 30 L, CE	66015234	FDA UDI	Class II	Active
Artic digital 8, D4 / 20 degree-34 UD, CE	66983285	FDA UDI	Class II	Active
Artic digital 6, C4 / TO40D, CE	66080536	FDA UDI	Class II	Active
Mondial 8, B2 / 37 U, CE	66017359	FDA UDI	Class II	Active
Dynamix Mixing Tips (1 X 50)	60035999	FDA UDI	Class II	Active
Artic 8, A4 / 10 degree - 30 U, CE	66015143	FDA UDI	Class II	Active
Mondial 6, B2 / O457, CE	66017023	FDA UDI	Class II	Active
Artic 8, B2 / 0 degree - 30 L, CE	66015160	FDA UDI	Class II	Active
Mondial 8, C2 / 37 U, CE	66017399	FDA UDI	Class II	Active
Basic 6, C1 / U01, CE	56739250	FDA UDI	Class II	Unknown
Delara	66071585	FDA UDI	Class II	Active
Mondial 6, BL2 / T435, CE	66975586	FDA UDI	Class II	Active
Mondial 6i DS, A3 / L14, CE	66986278	FDA UDI	Class II	Unknown
Mondial 6i, D3 / L18, CE	66970827	FDA UDI	Class II	Active
Mondial 8i, D3 / 31 U, CE	66973912	FDA UDI	Class II	Active
Artic	66080772	FDA UDI	Class II	Active
Mondial 6i, D2 / O6, CE	66970797	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