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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 8 of 123

Device	Model / Reference	Registries	Class	Status
Artic 6, C3 / L 05, CE	66015030	FDA UDI	Class II	Active
Mondial 8i, C4 / 33L, CE	66973899	FDA UDI	Class II	Active
Premium 6, B2 / O6, CE	66007033	FDA UDI	Class II	Unknown
Basic 6, C3 / A13, CE	56739060	FDA UDI	Class II	Unknown
Basic 8, B3 / CU, CE	56739456	FDA UDI	Class II	Unknown
Artic digital 8, A3.5 / 10 degrees-30LD, CE	66080667	FDA UDI	Class II	Active
Artic digital 6, A3.5 / S30D, CE	66983037	FDA UDI	Class II	Active
Artic 8, D3 / 10 degree - 32 U, CE	66015245	FDA UDI	Class II	Active
Mondial 8 DS, A3.5 / 35 U, CE	66986651	FDA UDI	Class II	Unknown
Artic	66080589	FDA UDI	Class II	Active
HC-Zirkonia Schneide S1, 100g	66042089	FDA UDI	Class II	Unknown
Artic 8, BL3 / 0 degree - 30 U, CE	66970442	FDA UDI	Class II	Active
Mondial 8 DS, A3 / 37 U, CE	66986643	FDA UDI	Class II	Unknown
Mondial 6 DS, A1 / T442, CE	66985590	FDA UDI	Class II	Unknown
Charisma	66000109	FDA UDI	Class II	Active
Artic	66080279	FDA UDI	Class II	Active
Delara	66071467	FDA UDI	Class II	Active
Artic digital 6, B1 / T35D, CE	66080377	FDA UDI	Class II	Active
Artic 8, A3 / 10 degree - 30 L, CE	66015124	FDA UDI	Class II	Active
Cuttersil Light Green 1x140 Ml	65817930	FDA UDI	Class II	Active
Basic 8, A2 / CU, CE	56739450	FDA UDI	Class II	Unknown
Artic digital 8, A1 / 10 degrees-30LD, CE	66080637	FDA UDI	Class II	Active
Artic digital 8, B4 / 10 degrees-32 UD, CE	66080718	FDA UDI	Class II	Active
Artic digital 6, D4 / L25D, CE	66983185	FDA UDI	Class II	Active
Premium 8, A3 / SL, CE	66007269	FDA UDI	Class II	Unknown
Artic	66080626	FDA UDI	Class II	Active
Delara	66071635	FDA UDI	Class II	Active
Artic digital 6, B1 / L05D, CE	66080383	FDA UDI	Class II	Active
Artic 6, B1 / TO 30, CE	66012886	FDA UDI	Class II	Active
Mondial 8, C3 / 30 U, CE	66802172	FDA UDI	Class II	Active
Mondial 6, A2 / L369, CE	66016893	FDA UDI	Class II	Active
Artic digital 6, A2 / T35D, CE	66080289	FDA UDI	Class II	Active
Mondial 8, B1 / 28 U, CE	66802134	FDA UDI	Class II	Active
Mondial 6 DS, A3 / L384, CE	66985677	FDA UDI	Class II	Unknown
FLEXITIME DYNAMIX HT REFILL (3X2X380ml)	66035992	FDA UDI	Class II	Unknown
Venus Temp 2 Cartridge Refill A2	66049182	FDA UDI	Class II	Unknown
Delara	66071399	FDA UDI	Class II	Active
Mondial 6, C4 / O525, CE	66017193	FDA UDI	Class II	Active
Artic 6, A1 / R 20, CE	66014844	FDA UDI	Class II	Active
Mondial 6, B4 / R420, CE	66017068	FDA UDI	Class II	Active
PalaXpress ultra, R50 veined, 100g	66034264	FDA UDI	Class II	Unknown
Premium 8, B4 / XS, CE	66007291	FDA UDI	Class II	Unknown
Mondial 8, A1 / 28 U, CE	66802104	FDA UDI	Class II	Active
Artic 8, A1 / 0 degree - 32 U, CE	66015101	FDA UDI	Class II	Active
Dima	66081666	FDA UDI	Class II	Active
Mondial 6, C3 / S550, CE	66975617	FDA UDI	Class II	Active
Basic 8, A2 / EO, CE	56739562	FDA UDI	Class II	Unknown
Premium 6, D4 / R2, CE	66007058	FDA UDI	Class II	Unknown
Artic digital 6, D3 / S40D, CE	66983170	FDA UDI	Class II	Active
Mondial 6, A2 / T495, CE	66975525	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