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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 34 of 123

Device	Model / Reference	Registries	Class	Status
Delara	66071213	FDA UDI	Class II	Active
Durafill VS	66000030	FDA UDI	Class II	Active
Basic 6, B1 / P23, CE	56739230	FDA UDI	Class II	Unknown
Artic digital 6, C3 / T30D, CE	66983138	FDA UDI	Class II	Active
Artic digital 6, B2 / T35D, CE	66080399	FDA UDI	Class II	Active
Mondial 8i, C3 / XS, CE	66970958	FDA UDI	Class II	Active
HeraCeram Opaker OA3, 5 , 20g	66003306	FDA UDI	Class II	Unknown
Artic 6, C4 / T 20, CE	66014015	FDA UDI	Class II	Active
Mondial 6, C4 / T515, CE	66017189	FDA UDI	Class II	Active
Artic digital 8, C1 / 10 degrees-32LD, CE	66080729	FDA UDI	Class II	Active
Flexitime Fast&Scan Easy Putty 1x600 Ml	66045754	FDA UDI	Class II	Unknown
Artic	66080675	FDA UDI	Class II	Active
Venus Pearl	66048191	FDA UDI	Class II	Active
Mondial 6i, D2 / R2, CE	66970788	FDA UDI	Class II	Active
Mondial 8i, B1 / XS, CE	66970894	FDA UDI	Class II	Active
Artic digital 8, D4 / 20 degree-36 UD, CE	66983287	FDA UDI	Class II	Active
Mondial 6i, BL3 / R2, CE	66970678	FDA UDI	Class II	Active
VENUS DIAMOND SYRINGE REFILL 1x4G A3, 5	66035475	FDA UDI	Class II	Active
Premium 6, B3 / O2, CE	66006882	FDA UDI	Class II	Unknown
HeraCeram Stain Liquid univers. SLU, 2ml	66052541	FDA UDI	Class II	Unknown
Delara	66071537	FDA UDI	Class II	Active
Mondial 6, B1 / T435, CE	66975554	FDA UDI	Class II	Active
Mondial 8i, B4 / 35L, CE	66973853	FDA UDI	Class II	Active
Artic 8, C4 / 30 degree - 30 L, CE	66037068	FDA UDI	Class II	Active
Mondial 8i, BL3 / 37 U, CE	66973870	FDA UDI	Class II	Active
Artic 6, A2 / O 10, CE	66012869	FDA UDI	Class II	Active
Delara	66071365	FDA UDI	Class II	Active
Signum matrix	66019704	FDA UDI	Class II	Active
Artic digital 8, A3 / 20 degrees-30 UD, CE	66080660	FDA UDI	Class II	Active
Premium 6, B3 / L18, CE	66006952	FDA UDI	Class II	Unknown
Artic digital 6, C3 / T15D, CE	66080507	FDA UDI	Class II	Active
Delara	66071435	FDA UDI	Class II	Active
Delara	66071570	FDA UDI	Class II	Active
Artic digital 8, C2 / 20 degrees-30 UD, CE	66080740	FDA UDI	Class II	Active
Premium 6, D2 / S2, CE	66007104	FDA UDI	Class II	Unknown
Premium 6, C4 / O4, CE	66007023	FDA UDI	Class II	Unknown
Premium 6, C1 / T2, CE	66007148	FDA UDI	Class II	Unknown
Artic 6, C2 / L 30, CE	66012916	FDA UDI	Class II	Active
Artic	66080437	FDA UDI	Class II	Active
Mondial 6, D4 / O525, CE	66017277	FDA UDI	Class II	Active
Signum composite	66020034	FDA UDI	Class II	Active
Mondial 6, A1 / T405, CE	66016847	FDA UDI	Class II	Active
Mondial 6, C3 / T440, CE	66975619	FDA UDI	Class II	Active
Signum composite	66020021	FDA UDI	Class II	Active
Delara	66071277	FDA UDI	Class II	Active
Delara	66071267	FDA UDI	Class II	Active
Delara	66071139	FDA UDI	Class II	Active
Delara	66071554	FDA UDI	Class II	Active
Artic digital 8, D4 / 20 degree-32LD, CE	66983284	FDA UDI	Class II	Active
Artic	66080562	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