Is this your brand? Sign in to claim ownership.

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 22 of 123

Device	Model / Reference	Registries	Class	Status
Delara	66071530	FDA UDI	Class II	Active
Delara	66071162	FDA UDI	Class II	Active
Delara	66071243	FDA UDI	Class II	Active
Mondial 6, D3 / T515, CE	66017245	FDA UDI	Class II	Active
Artic digital 8, B2 / 20 degrees-30 UD, CE	66080700	FDA UDI	Class II	Active
Mondial 6i, D4 / R4, CE	66970833	FDA UDI	Class II	Active
Premium 8, B3 / XS, CE	66007290	FDA UDI	Class II	Unknown
Artic	66080430	FDA UDI	Class II	Active
Mondial 6i DS, A3.5 / L14, CE	66986300	FDA UDI	Class II	Unknown
Mondial 8, C4 / 29L, CE	66017412	FDA UDI	Class II	Active
Mondial 6, BL2 / O510, CE	66801022	FDA UDI	Class II	Active
Mondial 6, D3 / T450, CE	66017242	FDA UDI	Class II	Active
Artic digital 6, BL3 / L20D, CE	66983107	FDA UDI	Class II	Active
Mondial 6i, B3 / L24, CE	66970633	FDA UDI	Class II	Active
Artic	66080474	FDA UDI	Class II	Active
Delara	66071645	FDA UDI	Class II	Active
Signum universal bond	66079923	FDA UDI	Class II	Active
Kulzer	65607758	FDA UDI	Class I	Unknown
Premium 8, A4 / M, CE	66007223	FDA UDI	Class II	Unknown
Artic 8, A1 / 30 degree - 30 L, CE	66036996	FDA UDI	Class II	Active
Dima	66081675	FDA UDI	Class II	Active
Basic 6, D4 / P23, CE	56739240	FDA UDI	Class II	Unknown
Ibond Self Etch Single Dose Value Pack	66046245	FDA UDI	Class II	Unknown
Artic	66080282	FDA UDI	Class II	Active
Delara	66071291	FDA UDI	Class II	Active
Delara	66071581	FDA UDI	Class II	Active
Provil Novo L. R Cd2 1x(2x50ml)	66046471	FDA UDI	Class II	Unknown
Mondial 6, C2 / L384, CE	66017149	FDA UDI	Class II	Active
Artic 6, D3 / S 40, CE	66013999	FDA UDI	Class II	Active
Artic 8, B2 / 20 degree - 34 L, CE	66012971	FDA UDI	Class II	Active
Translux® Power Blue® Usa/Jp/Mex	66017507	FDA UDI	Class II	Unknown
Mondial 8, D2 / 33L, CE	66017426	FDA UDI	Class II	Active
Artic 6, B4 / L 50, CE	66014111	FDA UDI	Class II	Active
iBond	66088898	FDA UDI	Class II	Active
Mondial 6i, D3 / S4, CE	66970821	FDA UDI	Class II	Active
Artic 6, B3 / L 40, CE	66014101	FDA UDI	Class II	Active
Basic 6, D2 / P23, CE	56739238	FDA UDI	Class II	Unknown
Artic digital 6, A2 / S30D, CE	66983015	FDA UDI	Class II	Active
Artic 6, D2 / S 30, CE	66013989	FDA UDI	Class II	Active
Mondial 8i DS, B1 / 35L, CE	66986886	FDA UDI	Class II	Unknown
Artic 8, B2 / 0 degree - 32 L, CE	66015162	FDA UDI	Class II	Active
Artic 6, D3 / L 45, CE	66015081	FDA UDI	Class II	Active
Mondial 6i, B1 / L20, CE	66970587	FDA UDI	Class II	Active
Mondial 6i, C4 / R2, CE	66970766	FDA UDI	Class II	Active
Artic 6, C3 / S 10, CE	66013969	FDA UDI	Class II	Active
Artic	66080532	FDA UDI	Class II	Active
Mondial 8, BL3 / 29L, CE	66801125	FDA UDI	Class II	Active
Mondial 6i, C4 / L18, CE	66970783	FDA UDI	Class II	Active
Mondial 6, A3 / T515, CE	66016909	FDA UDI	Class II	Active
Dima	66081672	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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