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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 28 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8i, A3 / 31L, CE	66973801	FDA UDI	Class II	Active
Premium 6, B1 / T4, CE	66007160	FDA UDI	Class II	Unknown
VENUS DIAMOND SYRINGE REFILL 1x4G OXDC	66046738	FDA UDI	Class II	Active
Venus Temp 2 Cartridge Refill Bleach	66049185	FDA UDI	Class II	Unknown
Mondial 8i, A2 / 33 U, CE	66973794	FDA UDI	Class II	Active
Mondial 6i, D3 / R4, CE	66970811	FDA UDI	Class II	Active
Mondial 8i DS, B1 / 33 U, CE	66986883	FDA UDI	Class II	Unknown
Artic 6, A2 / L 05, CE	66014870	FDA UDI	Class II	Active
Delara	66071327	FDA UDI	Class II	Active
Delara	66071263	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 1x10x0, 25G BL	66039025	FDA UDI	Class II	Active
VENUS Diamond FLOW SYR 1 x 1, 8G - A4	66040360	FDA UDI	Class II	Active
Basic 6, B4 / L01, CE	56739073	FDA UDI	Class II	Unknown
Basic 6, C4 / U06, CE	56739333	FDA UDI	Class II	Unknown
Mondial 6i, B1 / O4, CE	66970576	FDA UDI	Class II	Active
Mondial 6, A3 / T440, CE	66975531	FDA UDI	Class II	Active
Mondial 8i, B1 / 37 U, CE	66973830	FDA UDI	Class II	Active
Mondial 8, B4 / 29 U, CE	66017371	FDA UDI	Class II	Active
Premium 6, D3 / T6, CE	66007185	FDA UDI	Class II	Unknown
Mondial 6, C2 / L382, CE	66017148	FDA UDI	Class II	Active
Basic 8, D3 / FU, CE	56739623	FDA UDI	Class II	Unknown
HeraCeram Schultermasse HM7, 20g	66003496	FDA UDI	Class II	Unknown
Delara	66071226	FDA UDI	Class II	Active
Artic 6, A1 / T 35, CE	66014850	FDA UDI	Class II	Active
Artic 8, C3 / 30 degree - 30 U, CE	66037061	FDA UDI	Class II	Active
Mondial 8, BL2 / 29 U, CE	66801114	FDA UDI	Class II	Active
Delara	66071623	FDA UDI	Class II	Active
Artic 8, C4 / 20 degree - 34 U, CE	66014159	FDA UDI	Class II	Active
Premium 6, B2 / S6, CE	66007129	FDA UDI	Class II	Unknown
Delara	66071135	FDA UDI	Class II	Active
Artic digital 6, B3 / O20D, CE	66080413	FDA UDI	Class II	Active
Mondial 8i, A3 / 31 U, CE	66973800	FDA UDI	Class II	Active
Mondial 6i, BL3 / S6, CE	66970690	FDA UDI	Class II	Active
Artic 8, A4 / 20 degree - 32 U, CE	66014136	FDA UDI	Class II	Active
VENUS Diamond FLOW PLT ASSORTMENT	66040367	FDA UDI	Class II	Unknown
HC-Zirkonia Dentin DA3, 100g	66042083	FDA UDI	Class II	Unknown
Mondial 6i, D3 / R8, CE	66970813	FDA UDI	Class II	Active
Mondial 6i, B4 / L18, CE	66970651	FDA UDI	Class II	Active
Basic 8, B2 / CU, CE	56739455	FDA UDI	Class II	Unknown
Premium 6, D3 / O4, CE	66007025	FDA UDI	Class II	Unknown
Artic 6, D2 / TO 20, CE	66015061	FDA UDI	Class II	Active
Delara	66071132	FDA UDI	Class II	Active
Venus Pearl	66098262	FDA UDI	Class II	Active
Mondial 6i, A3.5 / O2, CE	66970531	FDA UDI	Class II	Active
Artic 8, B4 / 20 degree - 32 L, CE	66014147	FDA UDI	Class II	Active
Premium 6, B4 / O4, CE	66007019	FDA UDI	Class II	Unknown
Mondial 6i, A3.5 / L24, CE	66970545	FDA UDI	Class II	Active
Mondial 6i, A1 / T6, CE	66970464	FDA UDI	Class II	Active
Basic 6, B1 / L05, CE	56739134	FDA UDI	Class II	Unknown
Basic 6, B4 / U05, CE	56739313	FDA UDI	Class II	Unknown

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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