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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 32 of 123

Device	Model / Reference	Registries	Class	Status
VENUS DIAMOND SYRINGE REFILL 1x4G AM	66035491	FDA UDI	Class II	Active
Artic digital 6, D2 / O10D, CE	66080544	FDA UDI	Class II	Active
Delara	66071472	FDA UDI	Class II	Active
Mondial 8i, C2 / XS, CE	66970950	FDA UDI	Class II	Active
Cara	66078597	FDA UDI	Class II	Active
Artic digital 6, A4 / O10D, CE	66080346	FDA UDI	Class II	Active
Artic digital 6, B3 / L05D, CE	66080427	FDA UDI	Class II	Active
Mondial 6, A3 / L378, CE	66016923	FDA UDI	Class II	Active
Artic digital 8, B2 / 20 degree-36LD, CE	66983228	FDA UDI	Class II	Active
Premium 8, B4 / SL, CE	66007275	FDA UDI	Class II	Unknown
Mondial 6, D3 / S453, CE	66017252	FDA UDI	Class II	Active
Mondial 6, B4 / L373, CE	66017090	FDA UDI	Class II	Active
Delara	66071143	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 2x10x0, 25G A3	66039011	FDA UDI	Class II	Active
Premium 8, BL3 / XS, CE	66803000	FDA UDI	Class II	Unknown
Mondial 8, D3 / 29 U, CE	66017431	FDA UDI	Class II	Active
Delara	66071134	FDA UDI	Class II	Active
Mondial 6, BL1 / L341, CE	66801012	FDA UDI	Class II	Unknown
Artic 8, BL3 / 30 degree - 30 L, CE	66970453	FDA UDI	Class II	Active
Mondial 6, BL2 / O457, CE	66801021	FDA UDI	Class II	Active
Artic digital 8, A3 / 20 degree-36LD, CE	66983204	FDA UDI	Class II	Active
Artic 8, C1 / 20 degree - 34 L, CE	66014166	FDA UDI	Class II	Active
Mondial 6, C2 / R420, CE	66017124	FDA UDI	Class II	Active
Artic 6, A3 / L 30, CE	66012912	FDA UDI	Class II	Active
Basic 6, A1 / L06, CE	56739145	FDA UDI	Class II	Unknown
Mondial 8, C3 / 33 U, CE	66017405	FDA UDI	Class II	Active
Basic 6, A1 / P23, CE	56739225	FDA UDI	Class II	Unknown
Durafill VS	66000008	FDA UDI	Class II	Active
Artic digital 6, B4 / O20D, CE	66080435	FDA UDI	Class II	Active
Basic 6, A2 / P23, CE	56739226	FDA UDI	Class II	Unknown
Basic 8, A4 / BU, CE	56739421	FDA UDI	Class II	Unknown
Mondial 6 DS, A3.5 / T450, CE	66985699	FDA UDI	Class II	Unknown
Artic digital 6, B1 / R30D, CE	66983057	FDA UDI	Class II	Active
Mondial 6i, A4 / R8, CE	66970549	FDA UDI	Class II	Active
Basic 6, B4 / L02, CE	56739089	FDA UDI	Class II	Unknown
Mondial 8i, A3.5 / ML, CE	66970883	FDA UDI	Class II	Active
Delara	66071207	FDA UDI	Class II	Active
Mondial 8, B1 / 29L, CE	66017342	FDA UDI	Class II	Active
Premium 8, C2 / M, CE	66007229	FDA UDI	Class II	Unknown
Venus Pearl	66096881	FDA UDI	Class II	Active
Basic 8, B3 / FU, CE	56739616	FDA UDI	Class II	Unknown
Mondial 6, D3 / T465, CE	66017243	FDA UDI	Class II	Active
Signum universal bond	66079927	FDA UDI	Class II	Active
Mondial 6i, A4 / T4, CE	66970551	FDA UDI	Class II	Active
Mondial 6, BL1 / L362, CE	66801013	FDA UDI	Class II	Unknown
Mondial 6, BL2 / S445, CE	66801030	FDA UDI	Class II	Active
Premium 8, C3 / LL, CE	66007214	FDA UDI	Class II	Unknown
Artic digital 6, D4 / R20D, CE	66983177	FDA UDI	Class II	Active
Mondial 6, BL1 / O510, CE	66800994	FDA UDI	Class II	Unknown
Basic 6, A3.5 / U07, CE	56739340	FDA UDI	Class II	Unknown

Related Companies

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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