Is this your brand? Sign in to claim ownership.

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 27 of 123

Device	Model / Reference	Registries	Class	Status
Delara	66071561	FDA UDI	Class II	Active
Mondial 8, A3 / 28L, CE	66802117	FDA UDI	Class II	Active
Artic digital 8, C1 / 20 degrees-30LD, CE	66080731	FDA UDI	Class II	Active
Artic digital 8, A2 / 20 degrees-30 UD, CE	66080650	FDA UDI	Class II	Active
Mondial 6, D4 / L362, CE	66017284	FDA UDI	Class II	Active
Artic digital 6, BL3 / TO30D, CE	66080623	FDA UDI	Class II	Active
Venus Pearl	66048142	FDA UDI	Class II	Active
Mondial 6, C2 / R483, CE	66017127	FDA UDI	Class II	Active
Delara	66071436	FDA UDI	Class II	Active
Mondial 8, BL3 / 30L, CE	66802215	FDA UDI	Class II	Active
Mondial 6i, D2 / R6, CE	66970790	FDA UDI	Class II	Active
Mondial 6i, B2 / S8, CE	66970603	FDA UDI	Class II	Active
Mondial 6i, A3 / L22, CE	66970522	FDA UDI	Class II	Active
VENUS FLOW SYR 1 x 1, 8G BASELINER WHITE	66014574	FDA UDI	Class II	Active
Artic digital 6, D4 / L05D, CE	66080603	FDA UDI	Class II	Active
HC-Zirkonia Dentin DB3, 20g	66020195	FDA UDI	Class II	Unknown
Delara	66071406	FDA UDI	Class II	Active
Delara	66071325	FDA UDI	Class II	Active
Artic 8, A2 / 30 degree - 30 L, CE	66037002	FDA UDI	Class II	Active
Artic 6, D3 / T 10, CE	66014008	FDA UDI	Class II	Active
Artic digital 6, A3 / L05D, CE	66080317	FDA UDI	Class II	Active
Delara	66071245	FDA UDI	Class II	Active
HC-Zirkonia Liner Gingiva, 2ml	66020184	FDA UDI	Class II	Unknown
HeraCeram Pastenopaker PO C1, 2ml	66003353	FDA UDI	Class II	Unknown
Basic 6, B1 / A10, CE	56739006	FDA UDI	Class II	Unknown
Mondial 8i, BL2 / M, CE	66970930	FDA UDI	Class II	Active
Mondial 6, B4 / S550, CE	66975577	FDA UDI	Class II	Active
Premium 6, B3 / L20, CE	66006968	FDA UDI	Class II	Unknown
Artic 6, D4 / TO 10, CE	66015092	FDA UDI	Class II	Active
Artic 6, A3 / L 20, CE	66012905	FDA UDI	Class II	Active
Mondial 8i, A4 / 33L, CE	66973819	FDA UDI	Class II	Active
Artic 6, BL3 / L 45, CE	66970434	FDA UDI	Class II	Active
Premium 6, A1 / T6, CE	66007171	FDA UDI	Class II	Unknown
Mondial 6, C3 / R410, CE	66017151	FDA UDI	Class II	Active
Mondial 6, B4 / R455, CE	66017070	FDA UDI	Class II	Active
Translux® Wave®	66055012	FDA UDI	Class II	Unknown
Delara	66071560	FDA UDI	Class II	Active
Artic 8, A4 / 20 degree - 30 L, CE	66014127	FDA UDI	Class II	Active
Basic 6, A3 / L03, CE	56739099	FDA UDI	Class II	Unknown
Basic 6, B1 / U03, CE	56739278	FDA UDI	Class II	Unknown
Artic 6, D4 / TO 30, CE	66014063	FDA UDI	Class II	Active
Artic 8, D3 / 20 degree - 34 U, CE	66014161	FDA UDI	Class II	Active
Delara	66071234	FDA UDI	Class II	Active
Delara	66071153	FDA UDI	Class II	Active
Premium 6, B3 / L14, CE	66006920	FDA UDI	Class II	Unknown
PalaXpress ultra, pink vein., 12000g Pu	66046222	FDA UDI	Class II	Unknown
VENUS DIAMOND PLT REFILL 1x10x0, 25G A4	66039013	FDA UDI	Class II	Active
PALA cre-active, maroon, 3 g	66033461	FDA UDI	Class II	Active
Artic digital 6, BL3 / O10D, CE	66080610	FDA UDI	Class II	Active
Basic 8, B2 / DO, CE	56739471	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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