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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 37 of 123

Device	Model / Reference	Registries	Class	Status
HeraCeram Mask MA shadow, 20g	66033973	FDA UDI	Class II	Unknown
Delara	66071228	FDA UDI	Class II	Active
Basic 8, A3 / FU, CE	56739611	FDA UDI	Class II	Unknown
Delara	66071326	FDA UDI	Class II	Active
Venus Diamond	66098260	FDA UDI	Class II	Active
Premium 6, C2 / S2, CE	66007101	FDA UDI	Class II	Unknown
Basic 6, B2 / A10, CE	56739007	FDA UDI	Class II	Unknown
Charisma ABC	66064793	FDA UDI	Class II	Active
Basic 6, B4 / A12, CE	56739041	FDA UDI	Class II	Unknown
Artic digital 6, C4 / R20D, CE	66983144	FDA UDI	Class II	Active
Artic 8, A2 / 0 degree - 30 L, CE	66015110	FDA UDI	Class II	Active
Signum Opaque F	66020071	FDA UDI	Class II	Active
Premium 6, B2 / O2, CE	66007000	FDA UDI	Class II	Unknown
Mondial 6i DS, A3 / L12, CE	66986277	FDA UDI	Class II	Unknown
Mondial 6, BL2 / S550, CE	66975585	FDA UDI	Class II	Active
Artic digital 6, D4 / T15D, CE	66080595	FDA UDI	Class II	Active
Artic	66080396	FDA UDI	Class II	Active
Artic	66080673	FDA UDI	Class II	Active
Delara	66071682	FDA UDI	Class II	Active
Artic 6, BL3 / S 30, CE	66970405	FDA UDI	Class II	Active
Basic 6, C2 / U01, CE	56739251	FDA UDI	Class II	Unknown
Mondial 6 DS, A3.5 / L398, CE	66985714	FDA UDI	Class II	Unknown
Flexitime Xtreme Heavy Tray Ref.12x50 Ml	66019684	FDA UDI	Class II	Unknown
Basic 6, A4 / L05, CE	56739133	FDA UDI	Class II	Unknown
Mondial 6i DS, A2 / L22, CE	66986261	FDA UDI	Class II	Unknown
Charisma	66000095	FDA UDI	Class II	Active
Charisma	66000105	FDA UDI	Class II	Active
Artic	66080498	FDA UDI	Class II	Active
Basic 6, B3 / U01, CE	56739248	FDA UDI	Class II	Unknown
Basic 6, B1 / L02, CE	56739086	FDA UDI	Class II	Unknown
Mondial 8, D2 / 37 U, CE	66017429	FDA UDI	Class II	Active
Artic 6, A4 / L 05, CE	66014918	FDA UDI	Class II	Active
Artic 6, B1 / TO 40, CE	66012893	FDA UDI	Class II	Active
Basic 6, C1 / U03, CE	56739282	FDA UDI	Class II	Unknown
HeraCeram Dentin DA2, 100g	66003369	FDA UDI	Class II	Unknown
Mondial 6 DS, A3 / T405, CE	66985659	FDA UDI	Class II	Unknown
Artic 6, C4 / L 10, CE	66014078	FDA UDI	Class II	Active
HeraCeram Schultermasse HM1, 20g	66003484	FDA UDI	Class II	Unknown
Mondial 6, BL1 / L331, CE	66801011	FDA UDI	Class II	Unknown
Premium 6, B3 / T2, CE	66007146	FDA UDI	Class II	Unknown
Mondial 6, A3.5 / T440, CE	66975539	FDA UDI	Class II	Active
Signum matrix	66030670	FDA UDI	Class II	Active
Premium 6, C1 / T6, CE	66007180	FDA UDI	Class II	Unknown
Artic 6, A2 / L 10, CE	66012897	FDA UDI	Class II	Active
Artic 8, A4 / 30 degree - 32 L, CE	66037022	FDA UDI	Class II	Active
Basic 6, D4 / U06, CE	56739336	FDA UDI	Class II	Unknown
Artic 8, B3 / 20 degree - 30 U, CE	66014119	FDA UDI	Class II	Active
Artic 6, B3 / O 10, CE	66014038	FDA UDI	Class II	Active
Venus Pearl	66048172	FDA UDI	Class II	Active
Artic digital 8, A3.5 / 20 degrees-30 UD, CE	66080670	FDA UDI	Class II	Active

Related Companies

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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