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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 26 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8, A1 / 35L, CE	66017298	FDA UDI	Class II	Active
Artic 8, A1 / 20 degree - 34 U, CE	66012959	FDA UDI	Class II	Active
Delara	66071644	FDA UDI	Class II	Active
Artic 6, A4 / S 40, CE	66013992	FDA UDI	Class II	Active
Artic digital 6, B4 / L25D, CE	66983097	FDA UDI	Class II	Active
Artic digital 6, BL3 / R30D, CE	66983101	FDA UDI	Class II	Active
Flexitime Medium Flow 1 X (2 X 50 Ml)	60041062	FDA UDI	Class II	Active
Delara	66071500	FDA UDI	Class II	Active
Delara	66071515	FDA UDI	Class II	Active
Mondial 6 DS, A1 / T452, CE	66985592	FDA UDI	Class II	Unknown
Delara	66071505	FDA UDI	Class II	Active
Premium 6, D4 / L22, CE	66006993	FDA UDI	Class II	Unknown
Artic	66080307	FDA UDI	Class II	Active
Mondial 6i, C3 / L18, CE	66970761	FDA UDI	Class II	Active
Mondial 8i, A4 / 35L, CE	66973821	FDA UDI	Class II	Active
VENUS Diamond FLOW PLT 20x0, 20G - CL	66040377	FDA UDI	Class II	Active
Artic 6, A2 / L 40, CE	66012918	FDA UDI	Class II	Active
Mondial 6, BL2 / R420, CE	66801025	FDA UDI	Class II	Active
VENUS Diamond FLOW SYR 1 x 1, 8G - A3.5	66040359	FDA UDI	Class II	Active
Artic 8, B4 / 30 degree - 30 U, CE	66037043	FDA UDI	Class II	Active
Mondial 8, D4 / 29 U, CE	66017441	FDA UDI	Class II	Active
Mondial 6, C2 / T442, CE	66017129	FDA UDI	Class II	Active
Premium 6, C2 / R6, CE	66007085	FDA UDI	Class II	Unknown
Delara	66071672	FDA UDI	Class II	Active
Delara	66071591	FDA UDI	Class II	Active
Artic	66080582	FDA UDI	Class II	Active
Basic 6, D4 / L02, CE	56739096	FDA UDI	Class II	Unknown
Mondial 6, D2 / L341, CE	66017227	FDA UDI	Class II	Active
Premium 6, BL3 / S6, CE	66802959	FDA UDI	Class II	Unknown
Mondial 8, A2 / 28L, CE	66802111	FDA UDI	Class II	Active
Mondial 8i, C3 / LL, CE	66970965	FDA UDI	Class II	Active
Mondial 8i, A4 / 31L, CE	66973817	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 1x10x0, 25G D3	66039020	FDA UDI	Class II	Active
Mondial 6, B2 / T435, CE	66975562	FDA UDI	Class II	Active
Artic 6, C1 / TO 30, CE	66014058	FDA UDI	Class II	Active
Artic 8, D2 / 10 degree - 32 L, CE	66015236	FDA UDI	Class II	Active
Artic 6, A2 / L 20, CE	66012904	FDA UDI	Class II	Active
Mondial 6i DS, A1 / L16, CE	66986235	FDA UDI	Class II	Unknown
Premium 6, BL3 / S4, CE	66802958	FDA UDI	Class II	Unknown
Basic 8, C4 / EU, CE	56739589	FDA UDI	Class II	Unknown
Basic 8, D3 / BU, CE	56739431	FDA UDI	Class II	Unknown
Flexitime Correct Flow 1 X (2 X 50 Ml)	66002186	FDA UDI	Class II	Unknown
Mondial 6 DS, A1 / L382, CE	66985604	FDA UDI	Class II	Unknown
Basic 8, A2 / EU, CE	56739578	FDA UDI	Class II	Unknown
Basic 6, B3 / U07, CE	56739344	FDA UDI	Class II	Unknown
Basic 8, A4 / DU, CE	56739485	FDA UDI	Class II	Unknown
Premium 6, B3 / R4, CE	66007066	FDA UDI	Class II	Unknown
Mondial 8, BL3 / 33 U, CE	66801128	FDA UDI	Class II	Active
Artic	66080714	FDA UDI	Class II	Active
Artic digital 6, D2 / T20D, CE	66080552	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