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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 7 of 123

Device	Model / Reference	Registries	Class	Status
HC-Zirkonia Schultermasse HM1, 20g	66020262	FDA UDI	Class II	Unknown
VENUS Diamond FLOW SYR 1 x 1, 8G - A2.5	66040357	FDA UDI	Class II	Active
Durafill VS	66000011	FDA UDI	Class II	Active
Mondial 6i, D3 / T4, CE	66970815	FDA UDI	Class II	Active
Basic 8, A2 / FO, CE	56739594	FDA UDI	Class II	Unknown
Mondial 6, D4 / R455, CE	66017266	FDA UDI	Class II	Active
Mondial 6i, A4 / R4, CE	66970547	FDA UDI	Class II	Active
Mondial 6i, A1 / O4, CE	66970466	FDA UDI	Class II	Active
Artic 8, A2 / 30 degree - 34 U, CE	66037005	FDA UDI	Class II	Active
VENUS Diamond FLOW	66100269	FDA UDI	Class II	Active
Flexitime Correct Flow 1 X (2 X 50 Ml)	66002186	FDA UDI	Class II	Active
Mondial 8i, B3 / 33 U, CE	66973842	FDA UDI	Class II	Active
Mondial 6, A3 / R455, CE	66016902	FDA UDI	Class II	Active
Mondial 8, D2 / 33 U, CE	66017425	FDA UDI	Class II	Active
Mondial 6i, B1 / T4, CE	66970573	FDA UDI	Class II	Active
Premium 8, B1 / L, CE	66007192	FDA UDI	Class II	Unknown
Artic 8, D4 / 20 degree - 32 L, CE	66014153	FDA UDI	Class II	Active
Artic 8, A3 / 10 degree - 32 U, CE	66015125	FDA UDI	Class II	Active
Premium 6, D4 / S2, CE	66007106	FDA UDI	Class II	Unknown
Artic 8, A4 / 0 degree - 32 L, CE	66015142	FDA UDI	Class II	Active
Flexitime Mono Phase 1 X 50 Ml Sample	66003640	FDA UDI	Class II	Active
Artic digital 6, C4 / R30D, CE	66983145	FDA UDI	Class II	Active
Artic digital 6, D2 / L20D, CE	66983162	FDA UDI	Class II	Active
Mondial 6, D3 / L315, CE	66017253	FDA UDI	Class II	Active
Delara	66071216	FDA UDI	Class II	Active
Mondial 6, BL1 / T450, CE	66801006	FDA UDI	Class II	Unknown
Artic 8, D3 / 30 degree - 32 U, CE	66037081	FDA UDI	Class II	Active
Premium 8, A1 / L, CE	66007187	FDA UDI	Class II	Unknown
Mondial 6i, A3 / S6, CE	66970514	FDA UDI	Class II	Active
Basic 8, B1 / EO, CE	56739566	FDA UDI	Class II	Unknown
FLEXITIME DYNAMIX MONO REFILL(1X2X380ml)	60035993	FDA UDI	Class II	Active
Basic 8, D3 / CU, CE	56739463	FDA UDI	Class II	Unknown
Basic 8, C2 / HO, CE	56739539	FDA UDI	Class II	Unknown
Artic 6 Living Mould Chart B1	40005510	FDA UDI	Class II	Active
Artic	66080400	FDA UDI	Class II	Active
Mondial 6, B3 / T450, CE	66017046	FDA UDI	Class II	Active
Mondial 8, A2 / 33L, CE	66017306	FDA UDI	Class II	Active
Mondial 6, C2 / L362, CE	66017144	FDA UDI	Class II	Active
Cara	66077970	FDA UDI	Class II	Active
Basic 6, C2 / L01, CE	56739075	FDA UDI	Class II	Unknown
Basic 6, A1 / U03, CE	56739273	FDA UDI	Class II	Unknown
Basic 8, A4 / HO, CE	56739533	FDA UDI	Class II	Unknown
VENUS Diamond FLOW	66100272	FDA UDI	Class II	Active
Premium 8, B1 / XSL, CE	66007304	FDA UDI	Class II	Unknown
Premium 6, A3.5 / T2, CE	66007142	FDA UDI	Class II	Unknown
Mondial 8i DS, B1 / 35 U, CE	66986885	FDA UDI	Class II	Unknown
Mondial 6, BL1 / R483, CE	66801000	FDA UDI	Class II	Unknown
Mondial 6, C2 / O444, CE	66017134	FDA UDI	Class II	Active
Artic 6, A2 / T 10, CE	66012841	FDA UDI	Class II	Active
Artic	66080795	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