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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 73 of 123

Device	Model / Reference	Registries	Class	Status
Delara	66071640	FDA UDI	Class II	Active
Mondial 6, BL3 / L378, CE	66801072	FDA UDI	Class II	Active
Mondial 8, BL3 / 28L, CE	66802213	FDA UDI	Class II	Active
VENUS Diamond FLOW SYR 1 x 1, 8G - A3	66040358	FDA UDI	Class II	Active
Artic 8, B4 / 10 degree - 30 L, CE	66015184	FDA UDI	Class II	Active
Artic 6, A3 / S 40, CE	66012835	FDA UDI	Class II	Active
Basic 8, A1 / FO, CE	56739593	FDA UDI	Class II	Unknown
Artic 8, B2 / 20 degree - 36 U, CE	66015167	FDA UDI	Class II	Active
Artic 8, D4 / 20 degree - 30 U, CE	66014126	FDA UDI	Class II	Active
dima Print Teeth & Temp	66087428	FDA UDI	Class II	Active
Basic 8, B4 / DU, CE	56739489	FDA UDI	Class II	Unknown
Basic 6, B1 / L04, CE	56739118	FDA UDI	Class II	Unknown
iBond Universal	66098280	FDA UDI	Class II	Active
Premium 8, B3 / L, CE	66007194	FDA UDI	Class II	Unknown
Artic 6, A4 / TO 20, CE	66014917	FDA UDI	Class II	Active
Mondial 6i DS, A1 / L24, CE	66986240	FDA UDI	Class II	Unknown
Artic digital 8, C2 / 20 degree-32 UD, CE	66983253	FDA UDI	Class II	Active
Basic 8, B2 / GU, CE	56739519	FDA UDI	Class II	Unknown
Basic 6, A3 / P21, CE	56739195	FDA UDI	Class II	Unknown
Delara	66071513	FDA UDI	Class II	Active
Signum cre-active	66033446	FDA UDI	Class II	Active
Delara	66071230	FDA UDI	Class II	Active
Artic 8, D4 / 20 degree - 36 U, CE	66015257	FDA UDI	Class II	Active
Mondial 6i, A1 / S6, CE	66970470	FDA UDI	Class II	Active
Venus Diamond	66096872	FDA UDI	Class II	Active
Basic 8, C3 / BU, CE	56739428	FDA UDI	Class II	Unknown
Delara	66071411	FDA UDI	Class II	Active
Artic	66080321	FDA UDI	Class II	Active
Artic digital 6, B2 / TO10D, CE	66080402	FDA UDI	Class II	Active
Mondial 6i, A3 / L20, CE	66970521	FDA UDI	Class II	Active
Mondial 6, A2 / L315, CE	66016889	FDA UDI	Class II	Active
Mondial 6i, A2 / L22, CE	66970500	FDA UDI	Class II	Active
Artic 8, BL3 / 20 degree - 32 U, CE	66970438	FDA UDI	Class II	Active
Basic 8, D2 / CO, CE	56739446	FDA UDI	Class II	Unknown
Delara	66071510	FDA UDI	Class II	Active
Artic digital 8, B4 / 20 degrees-30 UD, CE	66080720	FDA UDI	Class II	Active
Premium 8, BL3 / LL, CE	66803007	FDA UDI	Class II	Unknown
Signum matrix	66019677	FDA UDI	Class II	Active
Artic digital 6, A2 / S40D, CE	66983016	FDA UDI	Class II	Active
Mondial 6i, D2 / L12, CE	66970802	FDA UDI	Class II	Active
VENUS Diamond FLOW SYR 1 x 1, 8G - A1	66040354	FDA UDI	Class II	Active
VENUS Diamond FLOW PLT 20x0, 20g - A3	66040371	FDA UDI	Class II	Active
Premium 6, A1 / L20, CE	66006961	FDA UDI	Class II	Unknown
Charisma	66000085	FDA UDI	Class II	Active
Artic digital 6, B1 / TO30D, CE	66080381	FDA UDI	Class II	Active
Mondial 8i, D3 / LL, CE	66970989	FDA UDI	Class II	Active
Mondial 6 DS, A1 / O510, CE	66985573	FDA UDI	Class II	Unknown
Artic 8, A2 / 30 degree - 32 U, CE	66037003	FDA UDI	Class II	Active
Mondial 6i, A3 / S2, CE	66970512	FDA UDI	Class II	Active
Basic 6, B2 / L05, CE	56739135	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