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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 55 of 123

Device	Model / Reference	Registries	Class	Status
Venus Pearl	66048097	FDA UDI	Class II	Active
Artic digital 6, A3.5 / TO10D, CE	66080336	FDA UDI	Class II	Active
Delara	66071345	FDA UDI	Class II	Active
Delara	66071264	FDA UDI	Class II	Active
Artic digital 6, B4 / O10D, CE	66080434	FDA UDI	Class II	Active
Mondial 6, A3.5 / R455, CE	66016930	FDA UDI	Class II	Active
Artic digital 6, D2 / S40D, CE	66983159	FDA UDI	Class II	Active
FLEXITIME DYNAMIX MONO REFILL(1X2X380ml)	60035993	FDA UDI	Class II	Unknown
Artic digital 6, D4 / O30D, CE	66983176	FDA UDI	Class II	Active
Artic	66080693	FDA UDI	Class II	Active
Mondial 6i, D2 / S4, CE	66970799	FDA UDI	Class II	Active
dima Print Teeth & Temp	66047430	FDA UDI	Class II	Active
Artic 8, B1 / 20 degree - 36 U, CE	66015157	FDA UDI	Class II	Active
Artic 8, D2 / 20 degree - 36 L, CE	66015238	FDA UDI	Class II	Active
Premium 8, A1 / M, CE	66007219	FDA UDI	Class II	Unknown
Venus Pearl	66096877	FDA UDI	Class II	Active
Mondial 6i DS, B1 / O6, CE	66986338	FDA UDI	Class II	Unknown
Mondial 6, B2 / T495, CE	66975565	FDA UDI	Class II	Active
Basic 6, A3.5 / L01, CE	56739068	FDA UDI	Class II	Unknown
Mondial 6i, C2 / R8, CE	66970725	FDA UDI	Class II	Active
Basic 6, A4 / L02, CE	56739085	FDA UDI	Class II	Unknown
Mondial 6i, B1 / S6, CE	66970580	FDA UDI	Class II	Active
Delara	66071358	FDA UDI	Class II	Active
Mondial 6, A4 / T405, CE	66016960	FDA UDI	Class II	Active
Artic 6, C3 / L 10, CE	66014077	FDA UDI	Class II	Active
HeraCeram Stain Fluid universal SLU, 20ml	66055371	FDA UDI	Class II	Unknown
Charisma ABC	66064794	FDA UDI	Class II	Active
Delara	66071159	FDA UDI	Class II	Active
Basic 6, A4 / A10, CE	56739005	FDA UDI	Class II	Unknown
Mondial 8i, A2 / 31L, CE	66973793	FDA UDI	Class II	Active
Delara	66071237	FDA UDI	Class II	Active
Dispensing Gun 10:1	66036083	FDA UDI	Class I	Active
Artic 6, B2 / R 40, CE	66014942	FDA UDI	Class II	Active
Artic	66080326	FDA UDI	Class II	Active
Mondial 6 DS, A3 / T495, CE	66985667	FDA UDI	Class II	Unknown
Artic	66080299	FDA UDI	Class II	Active
Mondial 6, A1 / L378, CE	66016866	FDA UDI	Class II	Active
Artic digital 6, B3 / TO10D, CE	66080424	FDA UDI	Class II	Active
Delara	66071271	FDA UDI	Class II	Active
Mondial 6, A3 / L362, CE	66016920	FDA UDI	Class II	Active
Delara	66071261	FDA UDI	Class II	Active
Artic digital 8, C3 / 20 degree-34 UD, CE	66983261	FDA UDI	Class II	Active
Mondial 8 DS, A3.5 / 37 U, CE	66986653	FDA UDI	Class II	Unknown
Mondial 6, A1 / L398, CE	66016869	FDA UDI	Class II	Active
Mondial 6, A2 / S443, CE	66016886	FDA UDI	Class II	Active
Basic 6, C3 / U02, CE	56739268	FDA UDI	Class II	Unknown
Artic digital 6, D2 / TO05D, CE	66080555	FDA UDI	Class II	Active
Venus Pearl	66048186	FDA UDI	Class II	Active
Flexitime Heavy Tray 1 X 50 Ml Sample	66003639	FDA UDI	Class II	Active
Artic digital 6, A3 / T30D, CE	66983028	FDA UDI	Class II	Active

Related Companies

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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