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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 64 of 123

Device	Model / Reference	Registries	Class	Status
Delara	66071470	FDA UDI	Class II	Active
Mondial 6i, A1 / L24, CE	66970479	FDA UDI	Class II	Active
Mondial 6, BL2 / L382, CE	66801045	FDA UDI	Class II	Active
Mondial 6i, C3 / R6, CE	66970746	FDA UDI	Class II	Active
Artic 8, D2 / 20 degree - 30 L, CE	66014133	FDA UDI	Class II	Active
Artic 6, D2 / TO 40, CE	66014070	FDA UDI	Class II	Active
Artic 6, C3 / L 50, CE	66014113	FDA UDI	Class II	Active
Signum cre-active	66020057	FDA UDI	Class II	Active
Basic 6, A2 / A12, CE	56739034	FDA UDI	Class II	Unknown
Mondial 6, C2 / L373, CE	66017146	FDA UDI	Class II	Active
HeraCeram Schneide S3, 20g	66003402	FDA UDI	Class II	Unknown
Premium 8, BL3 / S, CE	66803002	FDA UDI	Class II	Unknown
Artic 8, C3 / 20 degree - 32 L, CE	66014149	FDA UDI	Class II	Active
Delara	66071684	FDA UDI	Class II	Active
Mondial 8i, D2 / M, CE	66970978	FDA UDI	Class II	Active
Mondial 6, A4 / T452, CE	66975548	FDA UDI	Class II	Active
Signum composite	66020006	FDA UDI	Class II	Active
Basic 6, D4 / P21, CE	56739208	FDA UDI	Class II	Unknown
Basic 6, D3 / L04, CE	56739127	FDA UDI	Class II	Unknown
Basic 6, D2 / A12, CE	56739046	FDA UDI	Class II	Unknown
Venus Pearl	66048093	FDA UDI	Class II	Active
PROVIL NOVO P FAST 1X900ml	66046473	FDA UDI	Class II	Unknown
Mondial 8i, A2 / LL, CE	66970869	FDA UDI	Class II	Active
Artic 8, D2 / 30 degree - 34 L, CE	66037078	FDA UDI	Class II	Active
Artic	66080349	FDA UDI	Class II	Active
Mondial 8i DS, A3 / 37 U, CE	66986839	FDA UDI	Class II	Unknown
Mondial 6, C3 / T435, CE	66975618	FDA UDI	Class II	Active
Mondial 8i, D3 / 35L, CE	66973917	FDA UDI	Class II	Active
Artic digital 8, C4 / 20 degree-34 UD, CE	66983267	FDA UDI	Class II	Active
Artic digital 6, A2 / R20D, CE	66983012	FDA UDI	Class II	Active
Delara	66071446	FDA UDI	Class II	Active
Artic	66080373	FDA UDI	Class II	Active
Mondial 6 DS, A2 / L398, CE	66985642	FDA UDI	Class II	Unknown
PalaXpress ultra, R50 veined, 12000g	66050212	FDA UDI	Class II	Unknown
Durafill VS	66000021	FDA UDI	Class II	Active
Artic 6, C2 / R 20, CE	66015004	FDA UDI	Class II	Active
Mondial 6i DS, A1 / L18, CE	66986236	FDA UDI	Class II	Unknown
Delara	66071615	FDA UDI	Class II	Active
Artic 8, A3 / 20 degree - 32 U, CE	66012947	FDA UDI	Class II	Active
Artic	66080284	FDA UDI	Class II	Active
Basic 6, B4 / L04, CE	56739121	FDA UDI	Class II	Unknown
Basic 6, C3 / U04, CE	56739300	FDA UDI	Class II	Unknown
Mondial 8, A1 / 29 U, CE	66017291	FDA UDI	Class II	Active
Mondial 8, BL3 / 31L, CE	66801127	FDA UDI	Class II	Active
Artic	66080345	FDA UDI	Class II	Active
Mondial 8i, A2 / 33L, CE	66973795	FDA UDI	Class II	Active
Mondial 8, C4 / 33L, CE	66017416	FDA UDI	Class II	Active
Mondial 8i, B3 / 31L, CE	66973841	FDA UDI	Class II	Active
Artic digital 6, D3 / TO05D, CE	66080577	FDA UDI	Class II	Active
Artic	66080633	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