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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 118 of 123

Device	Model / Reference	Registries	Class	Status
Artic 8, A1 / 20 degree - 30 U, CE	66012931	FDA UDI	Class II	Active
Mondial 6, B2 / L369, CE	66017033	FDA UDI	Class II	Active
Premium 6, D4 / T4, CE	66007170	FDA UDI	Class II	Unknown
Artic 8, A3 / 20 degree - 36 L, CE	66015128	FDA UDI	Class II	Active
Artic 6, B4 / L 10, CE	66014075	FDA UDI	Class II	Active
Premium 6, A3 / S4, CE	66007109	FDA UDI	Class II	Unknown
Artic 6, B4 / O 20, CE	66014048	FDA UDI	Class II	Active
Artic digital 6, C3 / TO20D, CE	66983139	FDA UDI	Class II	Active
VENUS Diamond FLOW SYR ASSORTMENT	66040353	FDA UDI	Class II	Unknown
Mondial 6, C1 / O444, CE	66017106	FDA UDI	Class II	Active
Mondial 6, B2 / O525, CE	66017025	FDA UDI	Class II	Active
HC-Zirkonia Schneide S2, 100g	66042090	FDA UDI	Class II	Unknown
Artic 8, A3 / 30 degree - 34 L, CE	66037012	FDA UDI	Class II	Active
Premium 6, B3 / O4, CE	66007018	FDA UDI	Class II	Unknown
Artic digital 6, BL3 / S30D, CE	66983103	FDA UDI	Class II	Active
Flexitime Dynamix Monophase Trial Kit	66035989	FDA UDI	Class II	Active
Artic 8, A4 / 20 degree - 34 L, CE	66014163	FDA UDI	Class II	Active
Basic 6, C1 / U04, CE	56739298	FDA UDI	Class II	Unknown
Artic 8, D2 / 10 degree - 30 U, CE	66015233	FDA UDI	Class II	Active
Artic 6, A2 / S 20, CE	66012820	FDA UDI	Class II	Active
Premium 8, D2 / XSL, CE	66007312	FDA UDI	Class II	Unknown
Basic 8, D3 / EO, CE	56739575	FDA UDI	Class II	Unknown
Mondial 8i, C4 / 37 U, CE	66973902	FDA UDI	Class II	Active
Basic 6, D4 / L01, CE	56739080	FDA UDI	Class II	Unknown
Mondial 6i DS, A3.5 / L18, CE	66986302	FDA UDI	Class II	Unknown
Artic digital 6, A4 / S30D, CE	66983048	FDA UDI	Class II	Active
Mondial 8, A2 / 35L, CE	66017308	FDA UDI	Class II	Active
Premium 8, BL2 / L, CE	66802998	FDA UDI	Class II	Unknown
Premium 8, D3 / SL, CE	66007281	FDA UDI	Class II	Unknown
Artic 6, A4 / S 35, CE	66014912	FDA UDI	Class II	Active
Mondial 6 DS, A3.5 / S453, CE	66985692	FDA UDI	Class II	Unknown
Artic 6, B1 / L 20, CE	66012907	FDA UDI	Class II	Active
Mondial 6, B1 / L369, CE	66017005	FDA UDI	Class II	Active
Mondial 6i, B2 / L14, CE	66970605	FDA UDI	Class II	Active
Mondial 6 DS, B1 / T442, CE	66985770	FDA UDI	Class II	Unknown
Artic 6, C3 / T 10, CE	66014005	FDA UDI	Class II	Active
Charisma ABC	66064772	FDA UDI	Class II	Active
Mondial 8, B4 / 32 U, CE	66802156	FDA UDI	Class II	Active
Mondial 8 DS, A2 / 37L, CE	66986634	FDA UDI	Class II	Unknown
Artic 6, A2 / TO 20, CE	66014869	FDA UDI	Class II	Active
Artic 6, A3 / L 05, CE	66014886	FDA UDI	Class II	Active
Artic 6, A3 / TO 05, CE	66014883	FDA UDI	Class II	Active
Artic	66080429	FDA UDI	Class II	Active
Delara	66071276	FDA UDI	Class II	Active
Mondial 8, B1 / 30 U, CE	66802136	FDA UDI	Class II	Active
Premium 6, D3 / L20, CE	66006975	FDA UDI	Class II	Unknown
Artic digital 6, B1 / O10D, CE	66080368	FDA UDI	Class II	Active
Basic 8, D3 / DO, CE	56739479	FDA UDI	Class II	Unknown
Delara	66071654	FDA UDI	Class II	Active
Mondial 6i, C3 / L24, CE	66970765	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