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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 6 of 123

Device	Model / Reference	Registries	Class	Status
Artic	66080560	FDA UDI	Class II	Active
Premium 6, C2 / L22, CE	66006988	FDA UDI	Class II	Unknown
Mondial 6, C2 / T440, CE	66975611	FDA UDI	Class II	Active
Artic	66080695	FDA UDI	Class II	Active
Mondial 8, C4 / 30L, CE	66802179	FDA UDI	Class II	Active
Mondial 8i DS, A3 / 31 U, CE	66986833	FDA UDI	Class II	Unknown
Mondial 6, A2 / S502, CE	66975520	FDA UDI	Class II	Active
Mondial 8i, C4 / 35 U, CE	66973900	FDA UDI	Class II	Active
Mondial 8i, A4 / SL, CE	66970889	FDA UDI	Class II	Active
Venus Bulk Flow ONE	66098279	FDA UDI	Class II	Active
Basic 6, B4 / U04, CE	56739297	FDA UDI	Class II	Unknown
Signum matrix	66019700	FDA UDI	Class II	Active
Delara	66071621	FDA UDI	Class II	Active
Basic 8, D4 / CO, CE	56739448	FDA UDI	Class II	Unknown
Basic 6, D2 / U03, CE	56739286	FDA UDI	Class II	Unknown
Premium 6, B3 / T6, CE	66007178	FDA UDI	Class II	Unknown
Mondial 8, BL3 / 29 U, CE	66801124	FDA UDI	Class II	Active
Premium 8, BL3 / M, CE	66803004	FDA UDI	Class II	Unknown
Mondial 6, B4 / T515, CE	66017077	FDA UDI	Class II	Active
Mondial 8, A4 / 35 U, CE	66017337	FDA UDI	Class II	Active
Mondial 8i, A3 / 37 U, CE	66973806	FDA UDI	Class II	Active
Mondial 8, B3 / 29 U, CE	66017361	FDA UDI	Class II	Active
Premium 6, C1 / O6, CE	66007036	FDA UDI	Class II	Unknown
Durafill VS	66000010	FDA UDI	Class II	Active
Artic 6, D2 / TO 05, CE	66015059	FDA UDI	Class II	Active
Premium 6, D4 / S6, CE	66007138	FDA UDI	Class II	Unknown
Basic 8, A3.5 / EO, CE	56739564	FDA UDI	Class II	Unknown
Mondial 6i, A3.5 / T4, CE	66970529	FDA UDI	Class II	Active
Basic 8, A4 / EU, CE	56739581	FDA UDI	Class II	Unknown
Venus Diamond	66098277	FDA UDI	Class II	Active
Mondial 6, C1 / L373, CE	66017118	FDA UDI	Class II	Active
Artic 8, B3 / 10 degree - 30 L, CE	66015174	FDA UDI	Class II	Active
Artic 6, A3 / T 10, CE	66012842	FDA UDI	Class II	Active
Premium 6, A2 / T6, CE	66007172	FDA UDI	Class II	Unknown
Venus Diamond	66096870	FDA UDI	Class II	Active
Basic 8, C3 / GU, CE	56739524	FDA UDI	Class II	Unknown
HeraCeram Dentin DA2, 20g	66003368	FDA UDI	Class II	Unknown
Mondial 6i, B1 / R6, CE	66970570	FDA UDI	Class II	Active
Basic 8, D2 / HU, CE	56739558	FDA UDI	Class II	Unknown
Artic digital 6, C1 / S40D, CE	66983115	FDA UDI	Class II	Active
Mondial 6, B4 / L331, CE	66017086	FDA UDI	Class II	Active
Artic 8, A3.5 / 20 degree - 32 L, CE	66012955	FDA UDI	Class II	Active
VENUS FLOW SYR 1 x 1, 8G - T2	66014575	FDA UDI	Class II	Active
Mondial 8, D2 / 35 U, CE	66017427	FDA UDI	Class II	Active
Mondial 6, D4 / R449, CE	66017265	FDA UDI	Class II	Active
Premium 8, B1 / ML, CE	66007240	FDA UDI	Class II	Unknown
Premium 6, D4 / L20, CE	66006976	FDA UDI	Class II	Unknown
Mondial 6, BL3 / R410, CE	66801052	FDA UDI	Class II	Active
Mondial 8, B4 / 37L, CE	66017380	FDA UDI	Class II	Active
Mondial 6, A3.5 / R449, CE	66016929	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