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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 66 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 6, C1 / R410, CE	66017095	FDA UDI	Class II	Active
Delara	66071233	FDA UDI	Class II	Active
Delara	66071152	FDA UDI	Class II	Active
Mondial 6, BL2 / O525, CE	66801023	FDA UDI	Class II	Active
Ck Bite Yellow Economy	50095194	FDA UDI	Class I	Active
Artic 8, BL3 / 0 degree - 32 L, CE	66970445	FDA UDI	Class II	Active
PALA cre-active, gingiva, shade 200, 3 g	66033464	FDA UDI	Class II	Active
Artic 6, A1 / TO 05, CE	66014851	FDA UDI	Class II	Active
VENUS Diamond FLOW SYR 1 x 1, 8G - BXL	66040365	FDA UDI	Class II	Active
Mondial 6, B2 / L384, CE	66017037	FDA UDI	Class II	Active
Artic 6, C2 / S 20, CE	66012825	FDA UDI	Class II	Active
Artic digital 6, A3.5 / R20D, CE	66983034	FDA UDI	Class II	Active
Artic digital 6, B1 / L55D, CE	66983065	FDA UDI	Class II	Active
Mondial 6i, B2 / R4, CE	66970591	FDA UDI	Class II	Active
Mondial 8i, B3 / ML, CE	66970915	FDA UDI	Class II	Active
Mondial 6, BL1 / L382, CE	66801017	FDA UDI	Class II	Unknown
Mondial 8i, B1 / LL, CE	66970901	FDA UDI	Class II	Active
Delara	66071504	FDA UDI	Class II	Active
Mondial 6, B4 / R483, CE	66017071	FDA UDI	Class II	Active
Mondial 8, A4 / 29 U, CE	66017331	FDA UDI	Class II	Active
Mondial 6, D3 / S443, CE	66017250	FDA UDI	Class II	Active
Artic 8, C2 / 20 degree - 30 L, CE	66012944	FDA UDI	Class II	Active
Basic 6, C2 / L05, CE	56739139	FDA UDI	Class II	Unknown
Artic digital 6, D2 / L25D, CE	66983163	FDA UDI	Class II	Active
Mondial 6i, D4 / L20, CE	66970851	FDA UDI	Class II	Active
Artic digital 6, C3 / TO10D, CE	66080512	FDA UDI	Class II	Active
Mondial 6i, A3.5 / L16, CE	66970540	FDA UDI	Class II	Active
Delara	66071312	FDA UDI	Class II	Active
Delara	66071150	FDA UDI	Class II	Active
Basic 6, D3 / U02, CE	56739271	FDA UDI	Class II	Unknown
Artic 8, A3 / 30 degree - 34 U, CE	66037011	FDA UDI	Class II	Active
Artic digital 6, B4 / L20D, CE	66983096	FDA UDI	Class II	Active
Mondial 6, B3 / R449, CE	66017041	FDA UDI	Class II	Active
Flexitime Bite Cartridge Sample 1x50ml	66042232	FDA UDI	Class II	Active
Artic digital 8, A2 / 20 degree-32LD, CE	66983194	FDA UDI	Class II	Active
Flexitime Dynamix Heavy & Flow Trial Kit	66041071	FDA UDI	Class II	Active
Mondial 6i DS, A2 / R4, CE	66986242	FDA UDI	Class II	Unknown
Mondial 6, B1 / R520, CE	66975550	FDA UDI	Class II	Active
Artic 6, B3 / S 35, CE	66014960	FDA UDI	Class II	Active
Artic	66080432	FDA UDI	Class II	Active
Delara	66071441	FDA UDI	Class II	Active
Delara	66071360	FDA UDI	Class II	Active
Mondial 6i, B2 / S4, CE	66970601	FDA UDI	Class II	Active
Mondial 6, BL2 / L369, CE	66801042	FDA UDI	Class II	Active
Basic 8, A4 / GO, CE	56739501	FDA UDI	Class II	Unknown
Premium 6, A3 / L12, CE	66006899	FDA UDI	Class II	Unknown
Basic 6, D4 / A11, CE	56739032	FDA UDI	Class II	Unknown
Premium 6, D3 / O2, CE	66006889	FDA UDI	Class II	Unknown
Basic 6, D3 / P21, CE	56739207	FDA UDI	Class II	Unknown
Basic 6, D2 / L04, CE	56739126	FDA UDI	Class II	Unknown

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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