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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 103 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8i, B2 / ML, CE	66970907	FDA UDI	Class II	Active
Mondial 6i, BL2 / O4, CE	66970664	FDA UDI	Class II	Active
Mondial 8, A3.5 / 35L, CE	66017328	FDA UDI	Class II	Active
Artic 8, C3 / 30 degree - 30 L, CE	66037062	FDA UDI	Class II	Active
Premium 6, A2 / L16, CE	66006930	FDA UDI	Class II	Unknown
Venus Diamond	66081843	FDA UDI	Class II	Unknown
Mondial 6, BL3 / L362, CE	66801069	FDA UDI	Class II	Active
Artic 8, BL3 / 30 degree - 34 U, CE	66970456	FDA UDI	Class II	Active
Mondial 8, B1 / 32L, CE	66802139	FDA UDI	Class II	Active
Artic	66080591	FDA UDI	Class II	Active
Mondial 8, A1 / 30 U, CE	66802106	FDA UDI	Class II	Active
Artic 8, D3 / 0 degree - 30 U, CE	66015239	FDA UDI	Class II	Active
Mondial 6i, C4 / S6, CE	66970778	FDA UDI	Class II	Active
HeraCeram Schultermasse HM2, 20g	66003486	FDA UDI	Class II	Unknown
Mondial 6, B2 / T452, CE	66975564	FDA UDI	Class II	Active
Premium 6, C2 / T4, CE	66007165	FDA UDI	Class II	Unknown
Artic 8, B1 / 20 degree - 34 L, CE	66012970	FDA UDI	Class II	Active
Mondial 6i, A4 / S2, CE	66970556	FDA UDI	Class II	Active
Artic 8, B4 / 30 degree - 30 L, CE	66037044	FDA UDI	Class II	Active
Mondial 6, BL3 / R483, CE	66801056	FDA UDI	Class II	Active
Mondial 8, BL2 / 28L, CE	66802207	FDA UDI	Class II	Active
Artic digital 8, B4 / 20 degree-34LD, CE	66983238	FDA UDI	Class II	Active
Mondial 6i, BL3 / T4, CE	66970683	FDA UDI	Class II	Active
Mondial 6i DS, A1 / S8, CE	66986232	FDA UDI	Class II	Unknown
Mondial 6i, A1 / L14, CE	66970473	FDA UDI	Class II	Active
Cara	66088938	FDA UDI	Class II	Active
Artic digital 6, C2 / S40D, CE	66983126	FDA UDI	Class II	Active
Mondial 6i, D3 / T2, CE	66970814	FDA UDI	Class II	Active
Artic digital 6, A3.5 / T30D, CE	66983039	FDA UDI	Class II	Active
Mondial 6i, B1 / L12, CE	66970582	FDA UDI	Class II	Active
Mondial 8, D3 / 31L, CE	66017434	FDA UDI	Class II	Active
Mondial 6, C4 / O457, CE	66017191	FDA UDI	Class II	Active
Premium 6, C3 / T6, CE	66007182	FDA UDI	Class II	Unknown
VENUS FLOW SYR 1 x 1, 8G - OA2	66014570	FDA UDI	Class II	Active
Artic 6, A3.5 / T 10, CE	66012843	FDA UDI	Class II	Active
Mondial 6i, A3.5 / R8, CE	66970527	FDA UDI	Class II	Active
Artic digital 6, C2 / R20D, CE	66983122	FDA UDI	Class II	Active
Delara	66071214	FDA UDI	Class II	Active
Premium 8, D2 / LL, CE	66007216	FDA UDI	Class II	Unknown
Premium 8, D3 / M, CE	66007233	FDA UDI	Class II	Unknown
Artic 8, A2 / 20 degree - 36 U, CE	66015117	FDA UDI	Class II	Active
HeraCeram Dentin DA 3, 5 , 20g	66003372	FDA UDI	Class II	Unknown
Premium 6, B2 / O4, CE	66007017	FDA UDI	Class II	Unknown
Artic 6, BL3 / T 15, CE	66970426	FDA UDI	Class II	Active
Artic 8, B1 / 0 degree - 32 U, CE	66015151	FDA UDI	Class II	Active
Basic 6, B1 / U07, CE	56739342	FDA UDI	Class II	Unknown
Artic 8, D3 / 10 degree - 30 U, CE	66015243	FDA UDI	Class II	Active
Premium 8, B1 / M, CE	66007224	FDA UDI	Class II	Unknown
Delara	66071142	FDA UDI	Class II	Active
Mondial 8, A2 / 29L, CE	66017302	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