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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 121 of 123

Device	Model / Reference	Registries	Class	Status
Premium 6, D2 / L16, CE	66006942	FDA UDI	Class II	Unknown
Delara	66071526	FDA UDI	Class II	Active
Artic	66080615	FDA UDI	Class II	Active
Artic	66080453	FDA UDI	Class II	Active
Delara	66071543	FDA UDI	Class II	Active
Delara	66071462	FDA UDI	Class II	Active
PALA cre-active, gingiva, light pink, 3	66033466	FDA UDI	Class II	Active
Artic 8, B4 / 30 degree - 34 U, CE	66037047	FDA UDI	Class II	Active
Artic digital 6, A3.5 / TO05D, CE	66080335	FDA UDI	Class II	Active
Artic digital 8, B1 / 20 degree-34 UD, CE	66983219	FDA UDI	Class II	Active
Mondial 6i, BL3 / R8, CE	66970681	FDA UDI	Class II	Active
Basic 8, C4 / HU, CE	56739557	FDA UDI	Class II	Unknown
Artic 8, C4 / 20 degree - 34 L, CE	66014168	FDA UDI	Class II	Active
Basic 8, D2 / EO, CE	56739574	FDA UDI	Class II	Unknown
Artic 6, D3 / TO 10, CE	66015076	FDA UDI	Class II	Active
Basic 6, B2 / A11, CE	56739023	FDA UDI	Class II	Unknown
Basic 6, B3 / L03, CE	56739104	FDA UDI	Class II	Unknown
Artic 6, C4 / L 05, CE	66015046	FDA UDI	Class II	Active
Mondial 6i, B1 / L22, CE	66970588	FDA UDI	Class II	Active
Mondial 8i, A3 / M, CE	66970874	FDA UDI	Class II	Active
Delara	66071507	FDA UDI	Class II	Active
Artic	66080417	FDA UDI	Class II	Active
Mondial 8, BL3 / 28 U, CE	66802212	FDA UDI	Class II	Active
Mondial 8i, A1 / LL, CE	66970861	FDA UDI	Class II	Active
Artic 8, BL3 / 0 degree - 30 L, CE	66970443	FDA UDI	Class II	Active
Basic 6, A3.5 / A12, CE	56739036	FDA UDI	Class II	Unknown
Basic 8, C3 / CO, CE	56739444	FDA UDI	Class II	Unknown
Premium 6, D2 / L12, CE	66006910	FDA UDI	Class II	Unknown
Artic digital 6, A3 / TO05D, CE	66080313	FDA UDI	Class II	Active
HeraCeram Opal Transpa OTY, 100g	66003477	FDA UDI	Class II	Unknown
Mondial 6i, C2 / O4, CE	66970730	FDA UDI	Class II	Active
Artic 6, A3.5 / L 05, CE	66014902	FDA UDI	Class II	Active
Artic 8, A1 / 20 degree - 36 L, CE	66015108	FDA UDI	Class II	Active
Delara	66071410	FDA UDI	Class II	Active
Artic 6, C4 / TO 10, CE	66015044	FDA UDI	Class II	Active
Flexitime Medium Flow 6 X (2 X 50 Ml)	66041062	FDA UDI	Class II	Unknown
Artic 8, C4 / 10 degree - 30 U, CE	66015223	FDA UDI	Class II	Active
Basic 6, B2 / A12, CE	56739039	FDA UDI	Class II	Unknown
Artic 8, A1 / 20 degree - 36 U, CE	66015107	FDA UDI	Class II	Active
Flexitime Easy Putty & Flow Trial Kit	66041064	FDA UDI	Class II	Active
Premium 6, A2 / R2, CE	66007044	FDA UDI	Class II	Unknown
Artic 6, D2 / TO 10, CE	66015060	FDA UDI	Class II	Active
Basic 6, C4 / L03, CE	56739109	FDA UDI	Class II	Unknown
Basic 6, C3 / U06, CE	56739332	FDA UDI	Class II	Unknown
Mondial 8, C3 / 35L, CE	66017408	FDA UDI	Class II	Active
Mondial 8, A3.5 / 35 U, CE	66017327	FDA UDI	Class II	Active
Artic 6, B1 / O 10, CE	66012872	FDA UDI	Class II	Active
Mondial 6, B3 / L315, CE	66017057	FDA UDI	Class II	Active
Mondial 6, C2 / S443, CE	66017138	FDA UDI	Class II	Active
Mondial 6i, B4 / R2, CE	66970634	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