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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 107 of 123

Device	Model / Reference	Registries	Class	Status
Premium 6, BL3 / T4, CE	66802952	FDA UDI	Class II	Unknown
Basic 6, C2 / L03, CE	56739107	FDA UDI	Class II	Unknown
Mondial 6, BL1 / S443, CE	66801001	FDA UDI	Class II	Unknown
Artic 6, B1 / S 30, CE	66012830	FDA UDI	Class II	Active
Mondial 6, BL1 / L315, CE	66801010	FDA UDI	Class II	Unknown
Mondial 8i DS, A3.5 / 31 U, CE	66986849	FDA UDI	Class II	Unknown
Flexitime Heavy Tray 1x(2 X 50 Ml)	66002193	FDA UDI	Class II	Active
Mondial 6i, A3 / O6, CE	66970511	FDA UDI	Class II	Active
HeraCeram Schneide S2, 100g	66003401	FDA UDI	Class II	Unknown
Artic digital 6, D3 / R20D, CE	66983166	FDA UDI	Class II	Active
Basic 8, A4 / BO, CE	56739405	FDA UDI	Class II	Unknown
Mondial 6, A1 / T440, CE	66975515	FDA UDI	Class II	Active
Mondial 6i, C3 / L20, CE	66970763	FDA UDI	Class II	Active
Mondial 6i, BL3 / T2, CE	66970682	FDA UDI	Class II	Active
Premium 6, BL3 / L18, CE	66802963	FDA UDI	Class II	Unknown
Mondial 6 DS, A2 / O525, CE	66985610	FDA UDI	Class II	Unknown
Artic 6, D4 / L 20, CE	66014090	FDA UDI	Class II	Active
Premium 6, C3 / L20, CE	66006972	FDA UDI	Class II	Unknown
Artic digital 6, C1 / O10D, CE	66080456	FDA UDI	Class II	Active
Artic digital 8, B4 / 20 degrees-30LD, CE	66080721	FDA UDI	Class II	Active
Mondial/Mondial I Living Mould Chart B1	40005811	FDA UDI	Class II	Active
Mondial 6i, B1 / L19, CE	66970586	FDA UDI	Class II	Active
Artic 8, C1 / 20 degree - 32 U, CE	66014139	FDA UDI	Class II	Active
Artic digital 6, A3.5 / L25D, CE	66983042	FDA UDI	Class II	Active
Mondial 8, D2 / 31 U, CE	66017423	FDA UDI	Class II	Active
HC-Zirkonia Schultermasse HM5, 20g	66020266	FDA UDI	Class II	Unknown
Venus Diamond	66098265	FDA UDI	Class II	Active
Artic 8, B3 / 20 degree - 32 L, CE	66014146	FDA UDI	Class II	Active
Artic 6, A3.5 / L 55, CE	66014906	FDA UDI	Class II	Active
Premium 8, C1 / XS, CE	66007292	FDA UDI	Class II	Unknown
Basic 6, B1 / U06, CE	56739326	FDA UDI	Class II	Unknown
Mondial 6, A1 / T477, CE	66016851	FDA UDI	Class II	Active
Mondial 8, B3 / 37L, CE	66017370	FDA UDI	Class II	Active
Mondial 6, D2 / L362, CE	66017228	FDA UDI	Class II	Active
Artic 8, B3 / 0 degree - 32 L, CE	66015172	FDA UDI	Class II	Active
Basic 6, D2 / U07, CE	56739350	FDA UDI	Class II	Unknown
Artic 6, BL3 / R 40, CE	66970423	FDA UDI	Class II	Active
Mondial 6i, D4 / T6, CE	66970838	FDA UDI	Class II	Active
Artic digital 8, D2 / 20 degree-36 UD, CE	66983275	FDA UDI	Class II	Active
Artic 8, B3 / 30 degree - 32 U, CE	66037039	FDA UDI	Class II	Active
Mondial 6, C4 / S443, CE	66017194	FDA UDI	Class II	Active
Artic 6 Living Mould Chart A2	66015493	FDA UDI	Class II	Active
Delara	66071319	FDA UDI	Class II	Active
Artic 6, D2 / S 10, CE	66013971	FDA UDI	Class II	Active
Artic digital 8, B1 / 20 degree-36LD, CE	66983222	FDA UDI	Class II	Active
Artic 8, A1 / 30 degree - 34 U, CE	66036999	FDA UDI	Class II	Active
Mondial 6, BL1 / L384, CE	66801018	FDA UDI	Class II	Unknown
Artic	66080523	FDA UDI	Class II	Active
Artic digital 6, B4 / T20D, CE	66080442	FDA UDI	Class II	Active
Mondial 8, BL2 / 31 U, CE	66801116	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