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Kulzer, Inc.

Last updated September 17, 2026

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 14 of 123

Device	Model / Reference	Registries	Class	Status
Delara	66071376	FDA UDI	Class II	Active
Artic digital 6, C4 / T15D, CE	66080529	FDA UDI	Class II	Active
Premium 8, D4 / XS, CE	66007298	FDA UDI	Class II	Unknown
Artic 6, A1 / S 35, CE	66014848	FDA UDI	Class II	Active
Artic 6, BL3 / O 30, CE	66970420	FDA UDI	Class II	Active
Signum Opaque F	66020066	FDA UDI	Class II	Active
Mondial 8i DS, A2 / 35 U, CE	66986821	FDA UDI	Class II	Unknown
VENUS Diamond FLOW	66100273	FDA UDI	Class II	Active
Artic 6, D4 / L 10, CE	66014081	FDA UDI	Class II	Active
Artic digital 8, B4 / 10 degrees-30LD, CE	66080717	FDA UDI	Class II	Active
Delara	66071299	FDA UDI	Class II	Active
Venus Pearl	66048177	FDA UDI	Class II	Active
Venus Pearl	66048096	FDA UDI	Class II	Active
Delara	66071541	FDA UDI	Class II	Active
HeraCeram Glaze universal, 20g	66052907	FDA UDI	Class II	Unknown
Artic digital 8, C2 / 20 degree-36 UD, CE	66983257	FDA UDI	Class II	Active
Flexitime Xtreme Starter Kit	66019682	FDA UDI	Class II	Unknown
Signum cre-active	66020050	FDA UDI	Class II	Active
Delara	66071566	FDA UDI	Class II	Active
Delara	66071647	FDA UDI	Class II	Active
Artic digital 8, D2 / 10 degrees-32 UD, CE	66080768	FDA UDI	Class II	Active
Artic digital 8, C2 / 10 degrees-30 UD, CE	66080736	FDA UDI	Class II	Active
Mondial 6i DS, A3.5 / O2, CE	66986292	FDA UDI	Class II	Unknown
Artic 6, C2 / O 30, CE	66015003	FDA UDI	Class II	Active
Premium 6, B4 / L16, CE	66006937	FDA UDI	Class II	Unknown
Mondial 6, A3.5 / S550, CE	66975537	FDA UDI	Class II	Active
Artic digital 8, B3 / 10 degrees-32 UD, CE	66080708	FDA UDI	Class II	Active
Delara	66071474	FDA UDI	Class II	Active
Artic	66080546	FDA UDI	Class II	Active
Mondial 6i, BL3 / L19, CE	66970696	FDA UDI	Class II	Active
Artic 8, D4 / 30 degree - 30 L, CE	66037086	FDA UDI	Class II	Active
Artic 6, A3.5 / R 20, CE	66014892	FDA UDI	Class II	Active
Artic digital 6, A4 / TO05D, CE	66080357	FDA UDI	Class II	Active
Mondial 6, A3.5 / T450, CE	66016934	FDA UDI	Class II	Active
Venus Pearl	66048163	FDA UDI	Class II	Active
Artic 6, B3 / L 20, CE	66014083	FDA UDI	Class II	Active
Artic 6, C3 / T 15, CE	66015025	FDA UDI	Class II	Active
Basic 6, C3 / L03, CE	56739108	FDA UDI	Class II	Unknown
Basic 6, A1 / U06, CE	56739321	FDA UDI	Class II	Unknown
Mondial 6, D3 / L362, CE	66017256	FDA UDI	Class II	Active
Artic 6, C4 / T 35, CE	66015042	FDA UDI	Class II	Active
Artic digital 6, C3 / R40D, CE	66983135	FDA UDI	Class II	Active
Mondial 8i, B2 / S, CE	66970904	FDA UDI	Class II	Active
Premium 6, BL3 / L12, CE	66802960	FDA UDI	Class II	Unknown
Charisma ABC	66064777	FDA UDI	Class II	Active
Mondial 6, BL3 / T452, CE	66975596	FDA UDI	Class II	Active
Basic 6, C3 / P22, CE	56739220	FDA UDI	Class II	Unknown
Mondial 6, A4 / R483, CE	66016959	FDA UDI	Class II	Active
Mondial 8i, D3 / L, CE	66970988	FDA UDI	Class II	Active
Artic 6, B4 / TO 05, CE	66014979	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