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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 59 of 123

Device	Model / Reference	Registries	Class	Status
Artic digital 6, C2 / O20D, CE	66080479	FDA UDI	Class II	Active
Artic	66080773	FDA UDI	Class II	Active
Delara	66071549	FDA UDI	Class II	Active
Mondial 6i DS, B1 / O4, CE	66986337	FDA UDI	Class II	Unknown
Mondial 8 DS, B1 / 31L, CE	66986668	FDA UDI	Class II	Unknown
Mondial 6, A3.5 / T405, CE	66016932	FDA UDI	Class II	Active
Charisma	66000114	FDA UDI	Class II	Active
Artic	66080598	FDA UDI	Class II	Active
Artic digital 8, A4 / 10 degrees-32LD, CE	66080679	FDA UDI	Class II	Active
Artic digital 8, D3 / 10 degrees-30LD, CE	66080777	FDA UDI	Class II	Active
Premium 6, A4 / S4, CE	66007111	FDA UDI	Class II	Unknown
Mondial 6, B1 / O510, CE	66016996	FDA UDI	Class II	Active
Mondial 8i DS, A2 / 37L, CE	66986824	FDA UDI	Class II	Unknown
Venus Pearl	66048198	FDA UDI	Class II	Active
Mondial 8i, A2 / 35 U, CE	66973796	FDA UDI	Class II	Active
Mondial 8 DS, A3 / 31L, CE	66986638	FDA UDI	Class II	Unknown
Mondial 8, C2 / 35L, CE	66017398	FDA UDI	Class II	Active
Mondial 6 DS, A1 / S445, CE	66985582	FDA UDI	Class II	Unknown
Delara	66071675	FDA UDI	Class II	Active
Mondial 6i, BL2 / R6, CE	66970658	FDA UDI	Class II	Active
Mondial 8i, C2 / S, CE	66970952	FDA UDI	Class II	Active
Mondial 6i, B1 / L16, CE	66970584	FDA UDI	Class II	Active
Artic	66080585	FDA UDI	Class II	Active
Mondial 6i, C4 / R8, CE	66970769	FDA UDI	Class II	Active
Mondial 6, A4 / S550, CE	66975545	FDA UDI	Class II	Active
Mondial 6i DS, A3.5 / L22, CE	66986305	FDA UDI	Class II	Unknown
Mondial 6, C1 / T440, CE	66975603	FDA UDI	Class II	Active
Mondial 6 DS, A1 / L398, CE	66985606	FDA UDI	Class II	Unknown
Artic 6, B4 / TO 10, CE	66014980	FDA UDI	Class II	Active
Delara	66071248	FDA UDI	Class II	Active
Artic 6, D3 / S 20, CE	66013981	FDA UDI	Class II	Active
Artic 6, B3 / L 55, CE	66014970	FDA UDI	Class II	Active
Mondial 6, B3 / T477, CE	66017048	FDA UDI	Class II	Active
Premium 6, C3 / T4, CE	66007166	FDA UDI	Class II	Unknown
Delara	66071390	FDA UDI	Class II	Active
Delara	66071633	FDA UDI	Class II	Active
Venus Pearl	66048143	FDA UDI	Class II	Active
Artic	66080550	FDA UDI	Class II	Active
Basic 6, A1 / P20, CE	56739177	FDA UDI	Class II	Unknown
Artic 8, A3.5 / 20 degree - 30 U, CE	66012934	FDA UDI	Class II	Active
Mondial 8, BL2 / 37 U, CE	66801122	FDA UDI	Class II	Active
Artic digital 6, C2 / R30D, CE	66983123	FDA UDI	Class II	Active
Mondial 6i, B4 / T4, CE	66970639	FDA UDI	Class II	Active
Mondial 6i, A1 / L20, CE	66970477	FDA UDI	Class II	Active
Artic 8, A3.5 / 20 degree - 36 L, CE	66015138	FDA UDI	Class II	Active
Gluma Desensitizer Single Dose 40x1 Pce	66001854	FDA UDI	Class II	Active
Artic 6, D3 / L 20, CE	66014089	FDA UDI	Class II	Active
Basic 6, A3 / U02, CE	56739259	FDA UDI	Class II	Unknown
Mondial 6 DS, A3.5 / S445, CE	66985690	FDA UDI	Class II	Unknown
Mondial 6, B3 / R410, CE	66017039	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