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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 113 of 123

Device	Model / Reference	Registries	Class	Status
Basic 6, A4 / U05, CE	56739309	FDA UDI	Class II	Unknown
HeraCeram Opalschneide OS2, 100g	66003463	FDA UDI	Class II	Unknown
Premium 6, BL2 / L22, CE	66802947	FDA UDI	Class II	Unknown
Artic 6, BL3 / S 40, CE	66970406	FDA UDI	Class II	Active
Artic 6, C2 / L 45, CE	66015017	FDA UDI	Class II	Active
Artic 6, D4 / O 10, CE	66014045	FDA UDI	Class II	Active
Basic 8, D3 / GO, CE	56739511	FDA UDI	Class II	Unknown
Artic digital 8, D3 / 10 degrees-32 UD, CE	66080778	FDA UDI	Class II	Active
Ivory	66076088	FDA UDI	Class I	Unknown
Mondial 8, C4 / 30 U, CE	66802178	FDA UDI	Class II	Active
Basic 6, D2 / P22, CE	56739222	FDA UDI	Class II	Unknown
Mondial 6, B3 / S550, CE	66975569	FDA UDI	Class II	Active
Mondial 8 DS, A2 / 37 U, CE	66986633	FDA UDI	Class II	Unknown
Mondial 6 DS, B1 / S445, CE	66985762	FDA UDI	Class II	Unknown
Mondial 8i, B1 / S, CE	66970896	FDA UDI	Class II	Active
Artic 6, C1 / S 10, CE	66013968	FDA UDI	Class II	Active
Mondial 8i, BL2 / SL, CE	66970929	FDA UDI	Class II	Active
Basic 6, D2 / P20, CE	56739190	FDA UDI	Class II	Unknown
Mondial 6, A3 / T405, CE	66016904	FDA UDI	Class II	Active
Premium 6, C4 / L16, CE	66006941	FDA UDI	Class II	Unknown
Delara	66071434	FDA UDI	Class II	Active
Artic	66080506	FDA UDI	Class II	Active
Artic 6, B2 / S 10, CE	66012817	FDA UDI	Class II	Active
Basic 6, A4 / U06, CE	56739325	FDA UDI	Class II	Unknown
Artic	66080785	FDA UDI	Class II	Active
Mondial 6 DS, A3 / S445, CE	66985654	FDA UDI	Class II	Unknown
Mondial 8i, B4 / ML, CE	66970923	FDA UDI	Class II	Active
Premium 6, C3 / S2, CE	66007102	FDA UDI	Class II	Unknown
Basic 6, B3 / L04, CE	56739120	FDA UDI	Class II	Unknown
Basic 6, B4 / P20, CE	56739185	FDA UDI	Class II	Unknown
Delara	66071330	FDA UDI	Class II	Active
Mondial 8i, C1 / 37 U, CE	66973878	FDA UDI	Class II	Active
Premium 6, D2 / L22, CE	66006991	FDA UDI	Class II	Unknown
Artic	66080475	FDA UDI	Class II	Active
Mondial 6, A4 / S445, CE	66016971	FDA UDI	Class II	Active
Mondial 6, A2 / L331, CE	66016890	FDA UDI	Class II	Active
Artic 6, A3.5 / T 35, CE	66014898	FDA UDI	Class II	Active
Artic 6, C4 / TO 20, CE	66015045	FDA UDI	Class II	Active
Premium 6, D4 / O4, CE	66007026	FDA UDI	Class II	Unknown
Artic 8, D4 / 20 degree - 32 U, CE	66014144	FDA UDI	Class II	Active
Artic 8, C3 / 10 degree - 30 L, CE	66015214	FDA UDI	Class II	Active
Delara	66071639	FDA UDI	Class II	Active
Premium 8, C1 / LL, CE	66007212	FDA UDI	Class II	Unknown
Mondial 6, C1 / S445, CE	66017111	FDA UDI	Class II	Active
Mondial 8, C1 / 28 U, CE	66802158	FDA UDI	Class II	Active
Mondial 6, D3 / S550, CE	66975641	FDA UDI	Class II	Active
Mondial 8i, D3 / XSL, CE	66970983	FDA UDI	Class II	Active
Mondial 6 DS, A3.5 / T477, CE	66985702	FDA UDI	Class II	Unknown
Mondial 6i DS, A1 / O6, CE	66986228	FDA UDI	Class II	Unknown
Mondial 6i, D4 / T2, CE	66970836	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