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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 21 of 123

Device	Model / Reference	Registries	Class	Status
Artic	66080322	FDA UDI	Class II	Active
Artic digital 6, BL3 / TO10D, CE	66080622	FDA UDI	Class II	Active
Venus Pearl	66048141	FDA UDI	Class II	Active
Delara	66071550	FDA UDI	Class II	Active
Mondial 6, BL3 / R420, CE	66801053	FDA UDI	Class II	Active
Gluma Desensitizer 1 X 5 Ml	65872354	FDA UDI	Class II	Active
Artic 6, BL3 / T 10, CE	66970407	FDA UDI	Class II	Active
Mondial 6i, A1 / S2, CE	66970468	FDA UDI	Class II	Active
Artic digital 6, D2 / R20D, CE	66983155	FDA UDI	Class II	Active
Artic digital 8, B4 / 20 degree-32LD, CE	66983236	FDA UDI	Class II	Active
Mondial 6i, C3 / L19, CE	66970762	FDA UDI	Class II	Active
Basic 6, D4 / A12, CE	56739048	FDA UDI	Class II	Unknown
Kulzer	65607758	FDA UDI	Class I	Active
HeraCeram Pastenopaker PO D3, 2ml	66003358	FDA UDI	Class II	Unknown
Provil Novo	65210096	FDA UDI	Class II	Unknown
Artic 8, A2 / 30 degree - 30 U, CE	66037001	FDA UDI	Class II	Active
Artic digital 6, A3 / R30D, CE	66983024	FDA UDI	Class II	Active
Artic 6, D2 / L 05, CE	66015062	FDA UDI	Class II	Active
Bite Reg Intraoral Tip Cd 96	66000905	FDA UDI	Class I	Active
Venus Bulk Flow ONE	66095335	FDA UDI	Class II	Active
Delara	66071588	FDA UDI	Class II	Active
Venus Pearl	66048179	FDA UDI	Class II	Active
Venus Pearl	66048098	FDA UDI	Class II	Active
Artic 6, C1 / L 05, CE	66014998	FDA UDI	Class II	Active
Basic 6, A1 / L04, CE	56739113	FDA UDI	Class II	Unknown
Mondial 8 DS, A2 / 35L, CE	66986632	FDA UDI	Class II	Unknown
Artic 6, A2 / L 55, CE	66014874	FDA UDI	Class II	Active
Artic 6, B3 / O 30, CE	66014955	FDA UDI	Class II	Active
Delara	66071652	FDA UDI	Class II	Active
Artic 6, A4 / T 20, CE	66014010	FDA UDI	Class II	Active
Mondial 6, D2 / L331, CE	66017226	FDA UDI	Class II	Active
Mondial 6, C2 / L369, CE	66017145	FDA UDI	Class II	Active
IBOND UNIVERSAL BOTTLE SAMPLE 1 x 2ML	66061469	FDA UDI	Class II	Active
Artic	66080278	FDA UDI	Class II	Active
Basic 8, D4 / FO, CE	56739608	FDA UDI	Class II	Unknown
Artic 8, C2 / 30 degree - 30 L, CE	66037056	FDA UDI	Class II	Active
Mondial 8, A1 / 29L, CE	66017292	FDA UDI	Class II	Active
Artic 6, A2 / R 40, CE	66014862	FDA UDI	Class II	Active
Mondial 8i DS, B1 / 37L, CE	66986888	FDA UDI	Class II	Unknown
Basic 8, B1 / FO, CE	56739598	FDA UDI	Class II	Unknown
Artic digital 6, D4 / L20D, CE	66983184	FDA UDI	Class II	Active
Artic	66080344	FDA UDI	Class II	Active
Artic digital 6, B3 / TO30D, CE	66080425	FDA UDI	Class II	Active
Artic 6, B4 / L 05, CE	66014982	FDA UDI	Class II	Active
Delara	66071186	FDA UDI	Class II	Active
Artic 8, D4 / 30 degree - 30 U, CE	66037085	FDA UDI	Class II	Active
Artic digital 6, A3.5 / L20D, CE	66983041	FDA UDI	Class II	Active
Artic digital 6, C1 / T20D, CE	66080464	FDA UDI	Class II	Active
VENUS PEARL PLT REFILL 20x0, 2G A4	66048145	FDA UDI	Class II	Active
Mondial 6i, A4 / S8, CE	66970559	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