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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 65 of 123

Device	Model / Reference	Registries	Class	Status
VENUS DIAMOND SYRINGE REFILL 1x4G BL	66035487	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 1x10x0, 25G C3	66039019	FDA UDI	Class II	Active
Mondial 8, D3 / 31 U, CE	66017433	FDA UDI	Class II	Active
Artic	66080665	FDA UDI	Class II	Active
Delara	66071534	FDA UDI	Class II	Active
Mondial 6i, B1 / S8, CE	66970581	FDA UDI	Class II	Active
Artic digital 6, B2 / T30D, CE	66983072	FDA UDI	Class II	Active
Artic	66080459	FDA UDI	Class II	Active
Artic digital 8, B4 / 10 degrees-32LD, CE	66080719	FDA UDI	Class II	Active
Artic digital 8, D2 / 20 degrees-30 UD, CE	66080770	FDA UDI	Class II	Active
Signum composite flow	66050346	FDA UDI	Class II	Active
Artic 8, A4 / 10 degree - 32 U, CE	66015145	FDA UDI	Class II	Active
Premium 8, B2 / XSL, CE	66007305	FDA UDI	Class II	Unknown
Mondial 8, C4 / 31 U, CE	66017413	FDA UDI	Class II	Active
Premium 8, B2 / ML, CE	66007241	FDA UDI	Class II	Unknown
Dima	66077055	FDA UDI	Class II	Active
Mondial 8, B3 / 35 U, CE	66017367	FDA UDI	Class II	Active
Durafill VS	66000016	FDA UDI	Class II	Active
Artic digital 6, A3.5 / TO40D, CE	66080338	FDA UDI	Class II	Active
Delara	66071283	FDA UDI	Class II	Active
Mondial 6 DS, B1 / L341, CE	66985779	FDA UDI	Class II	Unknown
Delara	66071239	FDA UDI	Class II	Active
Delara	66071158	FDA UDI	Class II	Active
Artic 8, B3 / 30 degree - 34 U, CE	66037041	FDA UDI	Class II	Active
Dynamix Speed 2 US	66093756	FDA UDI	Class I	Active
Delara	66071381	FDA UDI	Class II	Active
Artic	66080281	FDA UDI	Class II	Active
Artic 6, A4 / T 40, CE	66014028	FDA UDI	Class II	Active
HC-Zirkonia Zr-Adhesive, 3ml	66020166	FDA UDI	Class II	Unknown
Mondial 6, C4 / R520, CE	66975622	FDA UDI	Class II	Active
Mondial 6, A3.5 / T495, CE	66975541	FDA UDI	Class II	Active
Artic digital 6, C1 / O30D, CE	66983110	FDA UDI	Class II	Active
Basic 8, B2 / FU, CE	56739615	FDA UDI	Class II	Unknown
Basic 8, B2 / HU, CE	56739551	FDA UDI	Class II	Unknown
Mondial 6, A3 / O510, CE	66016912	FDA UDI	Class II	Active
Mondial 6i, A3.5 / O6, CE	66970533	FDA UDI	Class II	Active
Delara	66071246	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 2x10x0, 25G A1	66039008	FDA UDI	Class II	Active
Delara	66071506	FDA UDI	Class II	Active
Delara	66071344	FDA UDI	Class II	Active
Mondial 6 DS, A3.5 / T452, CE	66985700	FDA UDI	Class II	Unknown
Mondial 8i, A3.5 / S, CE	66970880	FDA UDI	Class II	Active
Artic digital 6, BL3 / T30D, CE	66983105	FDA UDI	Class II	Active
Artic digital 8, BL3 / 20 degree-36LD, CE	66983246	FDA UDI	Class II	Active
Artic 6, D3 / L 15, CE	66015079	FDA UDI	Class II	Active
Delara	66071209	FDA UDI	Class II	Active
Mondial 6, C4 / R455, CE	66017182	FDA UDI	Class II	Active
Mondial 6i, A1 / R2, CE	66970458	FDA UDI	Class II	Active
Mondial 6i, A2 / S6, CE	66970492	FDA UDI	Class II	Active
Mondial 6, C4 / R410, CE	66017179	FDA UDI	Class II	Active

Related Companies

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Authorities

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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