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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 9 of 123

Device	Model / Reference	Registries	Class	Status
Delara	66071490	FDA UDI	Class II	Active
Artic digital 6, A3.5 / R30D, CE	66983035	FDA UDI	Class II	Active
Delara	66071463	FDA UDI	Class II	Active
Artic 6, D2 / T 20, CE	66014016	FDA UDI	Class II	Active
Artic 6, C4 / L 50, CE	66014114	FDA UDI	Class II	Active
Mondial 6i DS, B1 / R8, CE	66986332	FDA UDI	Class II	Unknown
Basic 6, C4 / L06, CE	56739157	FDA UDI	Class II	Unknown
Mondial 6i, A3.5 / R2, CE	66970524	FDA UDI	Class II	Active
Mondial 8, B2 / 35L, CE	66017358	FDA UDI	Class II	Active
Artic 6, A1 / S 05, CE	66014847	FDA UDI	Class II	Active
Premium 6, A2 / O6, CE	66007028	FDA UDI	Class II	Unknown
Mondial 6, BL2 / L398, CE	66801047	FDA UDI	Class II	Active
Artic digital 6, B2 / O10D, CE	66080390	FDA UDI	Class II	Active
Mondial 6, BL2 / T452, CE	66975588	FDA UDI	Class II	Active
Mondial 6i, B4 / T2, CE	66970638	FDA UDI	Class II	Active
Basic 8, C3 / EO, CE	56739572	FDA UDI	Class II	Unknown
Delara	66071217	FDA UDI	Class II	Active
Artic 6, C4 / S 20, CE	66013979	FDA UDI	Class II	Active
Mondial 6, C2 / S453, CE	66017140	FDA UDI	Class II	Active
Charisma	66000099	FDA UDI	Class II	Active
Artic digital 6, C2 / L25D, CE	66983130	FDA UDI	Class II	Active
Premium 6, A3 / L14, CE	66006915	FDA UDI	Class II	Unknown
Dentist Living Teeth Mould Kit-Mondial	66055715	FDA UDI	Class II	Active
Delara	66071184	FDA UDI	Class II	Active
Artic 8, D3 / 30 degree - 34 U, CE	66037083	FDA UDI	Class II	Active
Mondial 8i, B1 / 33L, CE	66973827	FDA UDI	Class II	Active
Mondial 8, A1 / 32 U, CE	66802108	FDA UDI	Class II	Active
Delara	66071165	FDA UDI	Class II	Active
Artic 8, C3 / 30 degree - 32 L, CE	66037064	FDA UDI	Class II	Active
Artic digital 8, D2 / 20 degree-34 UD, CE	66983273	FDA UDI	Class II	Active
Basic 8, C3 / DO, CE	56739476	FDA UDI	Class II	Unknown
Artic	66080631	FDA UDI	Class II	Active
Artic digital 6, B3 / TO20D, CE	66983084	FDA UDI	Class II	Active
Mondial 6, D4 / T515, CE	66017273	FDA UDI	Class II	Active
Basic 8, C4 / DU, CE	56739493	FDA UDI	Class II	Unknown
Mondial 6 DS, A2 / L382, CE	66985640	FDA UDI	Class II	Unknown
Artic	66080732	FDA UDI	Class II	Active
Flexitime Xtreme 2 Heavy Tray 12x50 Ml	66044884	FDA UDI	Class II	Active
Mondial 6i, D4 / R8, CE	66970835	FDA UDI	Class II	Active
Basic 6, A2 / P20, CE	56739178	FDA UDI	Class II	Unknown
Basic 6, A1 / L03, CE	56739097	FDA UDI	Class II	Unknown
HC-Zirkonia Opalschneide OS2, 20g	66020250	FDA UDI	Class II	Unknown
Premium 6, B1 / S4, CE	66007112	FDA UDI	Class II	Unknown
Mondial 8, C4 / 31L, CE	66017414	FDA UDI	Class II	Active
Basic 8, D4 / FU, CE	56739624	FDA UDI	Class II	Unknown
Mondial 6i, A3 / T6, CE	66970508	FDA UDI	Class II	Active
Mondial 6i, B4 / O6, CE	66970643	FDA UDI	Class II	Active
Artic digital 6, A3.5 / R40D, CE	66983036	FDA UDI	Class II	Active
Artic digital 6, C1 / TO20D, CE	66983117	FDA UDI	Class II	Active
Mondial 6i, A2 / R4, CE	66970481	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