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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 101 of 123

Device	Model / Reference	Registries	Class	Status
Artic digital 8, C4 / 20 degree-36LD, CE	66983270	FDA UDI	Class II	Active
Artic digital 6, A1 / L20D, CE	66983008	FDA UDI	Class II	Active
Basic 6, C4 / A11, CE	56739029	FDA UDI	Class II	Unknown
Basic 8, C1 / GU, CE	56739522	FDA UDI	Class II	Unknown
Premium 6, D4 / L14, CE	66006928	FDA UDI	Class II	Unknown
Artic	66080571	FDA UDI	Class II	Active
Delara	66071438	FDA UDI	Class II	Active
Artic 6, B3 / TO 40, CE	66014065	FDA UDI	Class II	Active
Charisma	66000104	FDA UDI	Class II	Active
Mondial 8i DS, B1 / 31 U, CE	66986881	FDA UDI	Class II	Unknown
Artic 6, B1 / T 30, CE	66012858	FDA UDI	Class II	Active
PALA cre-active, pink, 3 g	66033449	FDA UDI	Class II	Active
Mondial 8, D4 / 30L, CE	66802197	FDA UDI	Class II	Active
Basic 6, C2 / U04, CE	56739299	FDA UDI	Class II	Unknown
VENUS PEARL SYRINGE REFILL 1x3G C1	66048185	FDA UDI	Class II	Active
Artic digital 6, BL3 / R20D, CE	66983100	FDA UDI	Class II	Active
Mondial 8, D3 / 30L, CE	66802191	FDA UDI	Class II	Active
Signum composite	66020014	FDA UDI	Class II	Active
Premium 6, BL2 / T6, CE	66802935	FDA UDI	Class II	Unknown
Mondial 8i, A1 / 37 U, CE	66973790	FDA UDI	Class II	Active
Mondial 8, D4 / 32L, CE	66802199	FDA UDI	Class II	Active
Signum composite	66020029	FDA UDI	Class II	Active
Basic 8, D2 / HO, CE	56739542	FDA UDI	Class II	Unknown
Premium 6, B1 / S2, CE	66007096	FDA UDI	Class II	Unknown
Mondial 6, B3 / L341, CE	66017059	FDA UDI	Class II	Active
Mondial 8i, A3.5 / L, CE	66970884	FDA UDI	Class II	Active
Artic 8, B1 / 20 degree - 30 L, CE	66012942	FDA UDI	Class II	Active
Artic 6, A1 / T 40, CE	66012861	FDA UDI	Class II	Active
Basic 6, C2 / U07, CE	56739347	FDA UDI	Class II	Unknown
Mondial 8, D4 / 30 U, CE	66802196	FDA UDI	Class II	Active
Basic 8, C1 / EO, CE	56739570	FDA UDI	Class II	Unknown
Mondial 6 DS, A3.5 / O525, CE	66985682	FDA UDI	Class II	Unknown
Basic 8, A3 / EO, CE	56739563	FDA UDI	Class II	Unknown
Basic 8, A2 / DU, CE	56739482	FDA UDI	Class II	Unknown
Mondial 6i, A3.5 / T2, CE	66970528	FDA UDI	Class II	Active
HeraCeram Pastenopaker PO D2, 2ml	66003357	FDA UDI	Class II	Unknown
Artic 6, C4 / R 40, CE	66015038	FDA UDI	Class II	Active
Artic 6, B4 / TO 40, CE	66014066	FDA UDI	Class II	Active
HeraCeram Dentin DA4, 20g	66003374	FDA UDI	Class II	Unknown
Mondial 6i, D2 / S2, CE	66970798	FDA UDI	Class II	Active
Basic 8, D4 / HU, CE	56739560	FDA UDI	Class II	Unknown
PALA cre-active, gingiva, clear, 3 g	66033467	FDA UDI	Class II	Active
Artic 6, A2 / O 30, CE	66014859	FDA UDI	Class II	Active
Mondial 6, C1 / L331, CE	66017114	FDA UDI	Class II	Active
Artic 6, A3 / S 20, CE	66012821	FDA UDI	Class II	Active
Artic 8, C2 / 20 degree - 36 U, CE	66015207	FDA UDI	Class II	Active
Mondial 6i, A2 / L16, CE	66970496	FDA UDI	Class II	Active
Artic digital 8, C2 / 20 degree-32LD, CE	66983254	FDA UDI	Class II	Active
Artic 6, C1 / L 10, CE	66014076	FDA UDI	Class II	Active
Premium 6, A3.5 / R2, CE	66007046	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