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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 24 of 123

Device	Model / Reference	Registries	Class	Status
Artic digital 8, B3 / 20 degree-32 UD, CE	66983229	FDA UDI	Class II	Active
Delara	66071300	FDA UDI	Class II	Active
Artic digital 6, C1 / TO10D, CE	66080468	FDA UDI	Class II	Active
Delara	66071236	FDA UDI	Class II	Active
Artic 6, A2 / R 20, CE	66014860	FDA UDI	Class II	Active
Artic 8, C1 / 30 degree - 34 L, CE	66037054	FDA UDI	Class II	Active
Artic	66080762	FDA UDI	Class II	Active
HeraCeram Schneide S1, 20g	66003398	FDA UDI	Class II	Unknown
Mondial 6, D2 / L369, CE	66017229	FDA UDI	Class II	Active
Premium 8, D4 / S, CE	66007266	FDA UDI	Class II	Unknown
Delara	66071145	FDA UDI	Class II	Active
Artic 8, B2 / 30 degree - 32 L, CE	66037034	FDA UDI	Class II	Active
Delara	66071260	FDA UDI	Class II	Active
Provil Novo	65220717	FDA UDI	Class II	Unknown
Artic digital 6, BL3 / L25D, CE	66983108	FDA UDI	Class II	Active
Mondial 6, BL1 / R455, CE	66800999	FDA UDI	Class II	Unknown
Venus Pearl	66098278	FDA UDI	Class II	Active
Artic digital 8, A3.5 / 20 degree-32LD, CE	66983206	FDA UDI	Class II	Active
Mondial 6i, B3 / L14, CE	66970627	FDA UDI	Class II	Active
Artic 8 Living Mould Chart A1	40005513	FDA UDI	Class II	Active
Artic digital 6, A4 / L55D, CE	66983054	FDA UDI	Class II	Active
Basic 8, C2 / CO, CE	56739443	FDA UDI	Class II	Unknown
Basic 6, D2 / U05, CE	56739318	FDA UDI	Class II	Unknown
Palapress Vario	64707892	FDA UDI	Class II	Active
Artic 6, D2 / O 30, CE	66015051	FDA UDI	Class II	Active
Artic 6, A3.5 / S 10, CE	66012815	FDA UDI	Class II	Active
Basic 8, C4 / HO, CE	56739541	FDA UDI	Class II	Unknown
Basic 8, C3 / CU, CE	56739460	FDA UDI	Class II	Unknown
Premium 6, BL2 / L16, CE	66802944	FDA UDI	Class II	Unknown
Mondial 6 DS, A1 / T405, CE	66985587	FDA UDI	Class II	Unknown
Premium 6, B1 / O2, CE	66006999	FDA UDI	Class II	Unknown
Artic digital 8, B1 / 10 degrees-32LD, CE	66080689	FDA UDI	Class II	Active
Mondial 6, C4 / L369, CE	66017201	FDA UDI	Class II	Active
Mondial 6, A3.5 / R483, CE	66016931	FDA UDI	Class II	Active
Mondial 8, BL3 / 31 U, CE	66801126	FDA UDI	Class II	Active
Mondial 8, A2 / 32L, CE	66802115	FDA UDI	Class II	Active
Mondial 6, B1 / S453, CE	66017000	FDA UDI	Class II	Active
Venus Bulk Fill Syringe Intro Kit A3+SE	66046793	FDA UDI	Class II	Unknown
Venus Pearl	66081847	FDA UDI	Class II	Unknown
Mondial 6i, C2 / L14, CE	66970737	FDA UDI	Class II	Active
Mondial 8i, A3.5 / 31L, CE	66973809	FDA UDI	Class II	Active
Artic 6, B1 / L 50, CE	66012928	FDA UDI	Class II	Active
VENUS FLOW SYR 1 x 1, 8G - A1	66014562	FDA UDI	Class II	Active
Venus Pearl	66081846	FDA UDI	Class II	Unknown
Mondial 6 DS, A3 / O525, CE	66985646	FDA UDI	Class II	Unknown
Artic digital 6, B1 / TO05D, CE	66080379	FDA UDI	Class II	Active
Artic 6, D3 / R 30, CE	66015069	FDA UDI	Class II	Active
Artic 6, D3 / S 35, CE	66015072	FDA UDI	Class II	Active
Artic digital 6, C3 / R30D, CE	66983134	FDA UDI	Class II	Active
Artic digital 6, A4 / L25D, CE	66983053	FDA UDI	Class II	Active

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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