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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 116 of 123

Device	Model / Reference	Registries	Class	Status
Delara	66071678	FDA UDI	Class II	Active
Basic 6, D2 / P21, CE	56739206	FDA UDI	Class II	Unknown
Mondial 6i, B2 / S2, CE	66970600	FDA UDI	Class II	Active
Delara	66071538	FDA UDI	Class II	Active
VENUS DIAMOND SYRINGE REFILL 1x4G YO	66035493	FDA UDI	Class II	Active
Premium 6, A3.5 / L22, CE	66006981	FDA UDI	Class II	Unknown
Delara	66071636	FDA UDI	Class II	Active
Basic 8, A2 / GO, CE	56739498	FDA UDI	Class II	Unknown
Artic 6, B4 / T 40, CE	66014030	FDA UDI	Class II	Active
Mondial 6, A4 / T465, CE	66016963	FDA UDI	Class II	Active
Artic digital 8, A1 / 10 degrees-32LD, CE	66080639	FDA UDI	Class II	Active
Delara	66071567	FDA UDI	Class II	Active
Mondial 6, A2 / L362, CE	66016892	FDA UDI	Class II	Active
Basic 6, C2 / A10, CE	56739011	FDA UDI	Class II	Unknown
Artic digital 8, A3 / 10 degrees-30 UD, CE	66080656	FDA UDI	Class II	Active
Provil Novo P Reg 1x900	66046474	FDA UDI	Class II	Unknown
Artic digital 8, C1 / 10 degrees-30LD, CE	66080727	FDA UDI	Class II	Active
Mondial 6, BL3 / L373, CE	66801071	FDA UDI	Class II	Active
Mondial 6i, D2 / L20, CE	66970807	FDA UDI	Class II	Active
Mondial 6i, B4 / S4, CE	66970645	FDA UDI	Class II	Active
Mondial 6i, A2 / R8, CE	66970483	FDA UDI	Class II	Active
Artic 8, B4 / 30 degree - 32 U, CE	66037045	FDA UDI	Class II	Active
Premium 6, C1 / R4, CE	66007068	FDA UDI	Class II	Unknown
Artic 6, A1 / L 40, CE	66012917	FDA UDI	Class II	Active
Mondial 6, A1 / R410, CE	66016841	FDA UDI	Class II	Active
Basic 8, D4 / GU, CE	56739528	FDA UDI	Class II	Unknown
Mondial 6 DS, A2 / L378, CE	66985639	FDA UDI	Class II	Unknown
Mondial 6 DS, B1 / T450, CE	66985771	FDA UDI	Class II	Unknown
Basic 6, B3 / P21, CE	56739200	FDA UDI	Class II	Unknown
Artic 6, D4 / R 20, CE	66015084	FDA UDI	Class II	Active
Artic 6, B1 / S 10, CE	66012816	FDA UDI	Class II	Active
Artic digital 6, B2 / S40D, CE	66983071	FDA UDI	Class II	Active
Artic	66080386	FDA UDI	Class II	Active
HeraCeram Opal-Transpa Cristal OTC, 20g	66008770	FDA UDI	Class II	Unknown
Paladon 65, clear, 1000 g	64707710	FDA UDI	Class II	Active
Delara	66071547	FDA UDI	Class II	Active
HeraCeram Pastenopaker PO C3, 2ml	66003355	FDA UDI	Class II	Unknown
Delara	66071210	FDA UDI	Class II	Active
Mondial 6 DS, A1 / L341, CE	66985599	FDA UDI	Class II	Unknown
Mondial 6 DS, A3 / S453, CE	66985656	FDA UDI	Class II	Unknown
Basic 6, A4 / A11, CE	56739021	FDA UDI	Class II	Unknown
Mondial 8i DS, A1 / 37 U, CE	66986807	FDA UDI	Class II	Unknown
Mondial 6, A1 / S445, CE	66016858	FDA UDI	Class II	Active
Delara	66071388	FDA UDI	Class II	Active
Delara	66071297	FDA UDI	Class II	Active
Basic 6, D2 / U06, CE	56739334	FDA UDI	Class II	Unknown
Basic 6, C4 / U01, CE	56739253	FDA UDI	Class II	Unknown
Mondial 8i, D4 / S, CE	66970992	FDA UDI	Class II	Active
Delara	66071409	FDA UDI	Class II	Active
Mondial 8, C1 / 29L, CE	66017382	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