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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 25 of 123

Device	Model / Reference	Registries	Class	Status
Delara	66071584	FDA UDI	Class II	Active
Venus Pearl	66048175	FDA UDI	Class II	Active
HeraCeram Dentin DA1, 100g	66003367	FDA UDI	Class II	Unknown
Artic	66080466	FDA UDI	Class II	Active
Artic	66080385	FDA UDI	Class II	Active
Delara	66071573	FDA UDI	Class II	Active
Artic digital 8, D3 / 20 degrees-30 UD, CE	66080780	FDA UDI	Class II	Active
Flexitime Correct Flow Bulk Pack 50x50ml	66067512	FDA UDI	Class II	Active
Mondial 8i, C3 / 33 U, CE	66973890	FDA UDI	Class II	Active
Artic 6, A2 / T 35, CE	66014866	FDA UDI	Class II	Active
Artic 6, B3 / S 20, CE	66013975	FDA UDI	Class II	Active
Signum composite	66020030	FDA UDI	Class II	Active
Delara	66071519	FDA UDI	Class II	Active
Mondial 6, A3.5 / R520, CE	66975534	FDA UDI	Class II	Active
Mondial 6i, A2 / L19, CE	66970498	FDA UDI	Class II	Active
Mondial 6, D2 / S502, CE	66975632	FDA UDI	Class II	Active
Artic digital 6, A1 / T35D, CE	66080267	FDA UDI	Class II	Active
Delara	66071523	FDA UDI	Class II	Active
Basic 6, C4 / L05, CE	56739141	FDA UDI	Class II	Unknown
Mondial 6, BL2 / R449, CE	66801026	FDA UDI	Class II	Active
Artic digital 6, C4 / T35D, CE	66080531	FDA UDI	Class II	Active
Delara	66071540	FDA UDI	Class II	Active
Basic 6, D4 / A10, CE	56739016	FDA UDI	Class II	Unknown
Artic digital 8, B3 / 20 degrees-30 UD, CE	66080710	FDA UDI	Class II	Active
Artic digital 8, D4 / 20 degree-32 UD, CE	66983283	FDA UDI	Class II	Active
Mondial 6, D3 / R483, CE	66017239	FDA UDI	Class II	Active
Premium 8, C1 / SL, CE	66007276	FDA UDI	Class II	Unknown
Artic digital 8, D3 / 10 degrees-30 UD, CE	66080776	FDA UDI	Class II	Active
Flexitime Xtreme 2 Trial Kit	66044893	FDA UDI	Class II	Active
Artic digital 6, B4 / T30D, CE	66983094	FDA UDI	Class II	Active
Mondial 8i, C1 / S, CE	66970944	FDA UDI	Class II	Active
Mondial 8 DS, A3 / 33 U, CE	66986639	FDA UDI	Class II	Unknown
Mondial 6, A4 / R449, CE	66016957	FDA UDI	Class II	Active
Artic 6, A3 / L 25, CE	66014888	FDA UDI	Class II	Active
Artic digital 8, A1 / 20 degrees-30LD, CE	66080641	FDA UDI	Class II	Active
Premium 8, C4 / XSL, CE	66007311	FDA UDI	Class II	Unknown
Mondial 8, A3 / 30 U, CE	66802118	FDA UDI	Class II	Active
Mondial 6 DS, B1 / T435, CE	66985768	FDA UDI	Class II	Unknown
Mondial 6 DS, B1 / L362, CE	66985780	FDA UDI	Class II	Unknown
Gluma	66077842	FDA UDI	Class II	Unknown
Mondial 6, B1 / O525, CE	66016997	FDA UDI	Class II	Active
Basic 6, A3.5 / A13, CE	56739052	FDA UDI	Class II	Unknown
Artic 8, B4 / 0 degree - 30 U, CE	66015179	FDA UDI	Class II	Active
Artic 6, C1 / L 45, CE	66015001	FDA UDI	Class II	Active
HC-Zirkonia Schneide S1, 20g	66020204	FDA UDI	Class II	Unknown
Artic 6, B2 / L 20, CE	66012908	FDA UDI	Class II	Active
Artic 6, B4 / S 30, CE	66013985	FDA UDI	Class II	Active
Premium 6, C1 / L16, CE	66006938	FDA UDI	Class II	Unknown
Basic 8, D3 / FO, CE	56739607	FDA UDI	Class II	Unknown
Delara	66071286	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