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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 109 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8i, A1 / L, CE	66970860	FDA UDI	Class II	Active
Artic	66080620	FDA UDI	Class II	Active
Premium 6, C1 / R6, CE	66007084	FDA UDI	Class II	Unknown
IBOND CERAMIC PRIMER 1x4ml	66061416	FDA UDI	Class II	Active
Artic 8, B2 / 30 degree - 34 U, CE	66037035	FDA UDI	Class II	Active
Artic 6, A4 / L 55, CE	66014922	FDA UDI	Class II	Active
Basic 8, D3 / CO, CE	56739447	FDA UDI	Class II	Unknown
Basic 6, C4 / U03, CE	56739285	FDA UDI	Class II	Unknown
Mondial 6i, C3 / L16, CE	66970760	FDA UDI	Class II	Active
Basic 6, B4 / L06, CE	56739153	FDA UDI	Class II	Unknown
Artic 8, B1 / 20 degree - 36 L, CE	66015158	FDA UDI	Class II	Active
Premium 8, A3 / ML, CE	66007237	FDA UDI	Class II	Unknown
Artic 8, D4 / 10 degree - 32 L, CE	66015256	FDA UDI	Class II	Active
HeraCeram Glaze universal, 2ml	66052911	FDA UDI	Class II	Active
Artic digital 8, D3 / 20 degree-34LD, CE	66983280	FDA UDI	Class II	Active
Mondial 8i DS, A3.5 / 37 U, CE	66986855	FDA UDI	Class II	Unknown
Basic 8, A3.5 / BU, CE	56739420	FDA UDI	Class II	Unknown
Artic digital 8, A4 / 20 degree-34LD, CE	66983214	FDA UDI	Class II	Active
VENUS DIAMOND PLT REF.2x10x0, 25G HKA2, 5	66039010	FDA UDI	Class II	Active
Basic 6, B3 / A10, CE	56739008	FDA UDI	Class II	Unknown
Mondial 6, BL1 / R420, CE	66800997	FDA UDI	Class II	Unknown
Artic digital 6, C4 / TO20D, CE	66983150	FDA UDI	Class II	Active
Delara	66071140	FDA UDI	Class II	Active
Ibond Universal Single Dose Intro Kit	66061420	FDA UDI	Class II	Unknown
Mondial 6i, A3.5 / L18, CE	66970541	FDA UDI	Class II	Active
Artic digital 8, A4 / 10 degrees-30 UD, CE	66080676	FDA UDI	Class II	Active
Mondial 6i, D2 / S8, CE	66970801	FDA UDI	Class II	Active
Artic digital 8, A4 / 20 degree-32 UD, CE	66983211	FDA UDI	Class II	Active
Artic digital 6, D4 / L55D, CE	66983186	FDA UDI	Class II	Active
Artic 6, C2 / T 35, CE	66015010	FDA UDI	Class II	Active
Artic	66080518	FDA UDI	Class II	Active
Artic	66080356	FDA UDI	Class II	Active
Mondial 6, BL3 / L384, CE	66801074	FDA UDI	Class II	Active
Signum composite	66020008	FDA UDI	Class II	Active
Artic 6, B2 / T 15, CE	66014945	FDA UDI	Class II	Active
Mondial 8, A1 / 31L, CE	66017294	FDA UDI	Class II	Active
Mondial 6i DS, B1 / R6, CE	66986331	FDA UDI	Class II	Unknown
Mondial 6i, BL3 / L24, CE	66970699	FDA UDI	Class II	Active
Mondial 6i, BL2 / R4, CE	66970657	FDA UDI	Class II	Active
Mondial 6i, B1 / R2, CE	66970568	FDA UDI	Class II	Active
Mondial 8i, C4 / 37L, CE	66973903	FDA UDI	Class II	Active
Mondial 6, C1 / T452, CE	66975604	FDA UDI	Class II	Active
Delara	66071670	FDA UDI	Class II	Active
Mondial 6, C3 / T495, CE	66975621	FDA UDI	Class II	Active
Mondial 6i, BL3 / S8, CE	66970691	FDA UDI	Class II	Active
Mondial 8, D3 / 33 U, CE	66017435	FDA UDI	Class II	Active
Mondial 8i, D4 / XS, CE	66970990	FDA UDI	Class II	Active
Artic 6, B2 / T 35, CE	66014946	FDA UDI	Class II	Active
Delara	66071181	FDA UDI	Class II	Active
Mondial 8i, A2 / SL, CE	66970865	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