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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 95 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8i, B2 / 33L, CE	66973835	FDA UDI	Class II	Active
Premium 8, BL2 / SL, CE	66802995	FDA UDI	Class II	Unknown
Mondial 6i, C1 / O6, CE	66970709	FDA UDI	Class II	Active
Mondial 8 DS, A2 / 33L, CE	66986630	FDA UDI	Class II	Unknown
Artic 6, BL3 / T 40, CE	66970410	FDA UDI	Class II	Active
PALA cre-active, gum, 3 g	66033468	FDA UDI	Class II	Active
Artic 6, A4 / L 15, CE	66014919	FDA UDI	Class II	Active
Artic 8, C1 / 30 degree - 30 U, CE	66037049	FDA UDI	Class II	Active
Provil Novo Mono R Cd2 1x(2x50ml)	66008294	FDA UDI	Class II	Unknown
Mondial 6, B1 / O457, CE	66016995	FDA UDI	Class II	Active
HeraCeram Farbindikator Bleach	66015636	FDA UDI	Class II	Unknown
Premium 6, B1 / O6, CE	66007032	FDA UDI	Class II	Unknown
Artic 8, A3.5 / 0 degree - 32 L, CE	66015132	FDA UDI	Class II	Active
Mondial 6, B3 / T465, CE	66017047	FDA UDI	Class II	Active
Mondial 8 DS, A1 / 37 U, CE	66986623	FDA UDI	Class II	Unknown
Artic 8, C3 / 30 degree - 34 L, CE	66037066	FDA UDI	Class II	Active
Delara	66071508	FDA UDI	Class II	Active
Delara	66071427	FDA UDI	Class II	Active
Delara	66071346	FDA UDI	Class II	Active
Artic digital 6, C4 / TO05D, CE	66080533	FDA UDI	Class II	Active
Signum Opaque F	66020080	FDA UDI	Class II	Active
Mondial 6, B1 / R449, CE	66016985	FDA UDI	Class II	Active
Mondial 6, A3 / T435, CE	66975530	FDA UDI	Class II	Active
Flexitime Fast&Scan Dyn.putty&Flow Trial	66044883	FDA UDI	Class II	Unknown
Premium 6, A3.5 / L18, CE	66006948	FDA UDI	Class II	Unknown
Mondial 6, B4 / T477, CE	66017076	FDA UDI	Class II	Active
VENUS FLOW SYR 1 x 1, 8G - A3	66014565	FDA UDI	Class II	Active
Artic digital 6, A2 / T15D, CE	66080287	FDA UDI	Class II	Active
Mondial 6, B4 / R520, CE	66975574	FDA UDI	Class II	Active
Mondial 6, B3 / S453, CE	66017056	FDA UDI	Class II	Active
Artic 6, A2 / L 50, CE	66012925	FDA UDI	Class II	Active
Basic 6, B2 / L02, CE	56739087	FDA UDI	Class II	Unknown
Basic 6, C3 / P20, CE	56739188	FDA UDI	Class II	Unknown
Artic 6, A3.5 / L 15, CE	66014903	FDA UDI	Class II	Active
Artic 8, BL3 / 20 degree - 30 L, CE	66970437	FDA UDI	Class II	Active
Xantasil	66052111	FDA UDI	Class II	Active
Basic 8, D2 / CU, CE	56739462	FDA UDI	Class II	Unknown
Premium 6, C2 / S4, CE	66007117	FDA UDI	Class II	Unknown
Artic 8, BL3 / 0 degree - 32 U, CE	66970444	FDA UDI	Class II	Active
Premium 6, BL2 / R4, CE	66802931	FDA UDI	Class II	Unknown
Basic 6, A1 / L02, CE	56739081	FDA UDI	Class II	Unknown
Artic digital 6, C3 / O30D, CE	66983132	FDA UDI	Class II	Active
Mondial 6i, C1 / R6, CE	66970702	FDA UDI	Class II	Active
Artic digital 6, A3 / L25D, CE	66983031	FDA UDI	Class II	Active
Artic digital 8, B1 / 20 degrees-30LD, CE	66080691	FDA UDI	Class II	Active
Signum Opaque F	66020068	FDA UDI	Class II	Active
Artic 6, D4 / L 40, CE	66014108	FDA UDI	Class II	Active
Signum Opaque F	66020075	FDA UDI	Class II	Active
Basic 6, A2 / L03, CE	56739098	FDA UDI	Class II	Unknown
Mondial 6, D4 / T440, CE	66975651	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