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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 96 of 123

Device	Model / Reference	Registries	Class	Status
Basic 6, A4 / U03, CE	56739277	FDA UDI	Class II	Unknown
Basic 6, D3 / L06, CE	56739159	FDA UDI	Class II	Unknown
Artic	66080283	FDA UDI	Class II	Active
Artic	66080410	FDA UDI	Class II	Active
Delara	66071167	FDA UDI	Class II	Active
Premium 6, B1 / L16, CE	66006934	FDA UDI	Class II	Unknown
Delara	66071265	FDA UDI	Class II	Active
Venus	66077636	FDA UDI	Class I	Active
Artic 8, A3 / 30 degree - 32 L, CE	66037010	FDA UDI	Class II	Active
Signum Opaque F	66020077	FDA UDI	Class II	Active
Mondial 6, D2 / L373, CE	66017230	FDA UDI	Class II	Active
Artic 6, D3 / O 20, CE	66014053	FDA UDI	Class II	Active
Artic digital 6, B1 / TO10D, CE	66080380	FDA UDI	Class II	Active
Artic 8, A4 / 0 degree - 30 L, CE	66015140	FDA UDI	Class II	Active
Mondial 8, A3.5 / 30 U, CE	66802124	FDA UDI	Class II	Active
dima Print Teeth & Temp	66087426	FDA UDI	Class II	Active
Mondial 8i, A3.5 / 37 U, CE	66973814	FDA UDI	Class II	Active
Basic 6, B3 / A11, CE	56739024	FDA UDI	Class II	Unknown
Premium 6, A3 / O2, CE	66006996	FDA UDI	Class II	Unknown
Mondial 6, A4 / L362, CE	66016976	FDA UDI	Class II	Active
Premium 6, D2 / O2, CE	66006888	FDA UDI	Class II	Unknown
Basic 8, B4 / CU, CE	56739457	FDA UDI	Class II	Unknown
Artic	66080389	FDA UDI	Class II	Active
Delara	66071398	FDA UDI	Class II	Active
Signum composite	66020007	FDA UDI	Class II	Active
Artic 6, D3 / L 50, CE	66014116	FDA UDI	Class II	Active
Mondial 8i, A4 / XSL, CE	66970887	FDA UDI	Class II	Active
Mondial 8i, D3 / SL, CE	66970985	FDA UDI	Class II	Active
Delara	66071189	FDA UDI	Class II	Active
Mondial 6, B1 / T440, CE	66975555	FDA UDI	Class II	Active
Mondial 6i DS, A3 / R4, CE	66986264	FDA UDI	Class II	Unknown
Mondial 6, D4 / T495, CE	66975653	FDA UDI	Class II	Active
Mondial 6, B3 / T452, CE	66975572	FDA UDI	Class II	Active
Premium 6, C4 / L22, CE	66006990	FDA UDI	Class II	Unknown
Flexitime Easy Putty 1 X 600 Ml	50034802	FDA UDI	Class II	Active
Premium 6, A2 / L18, CE	66006946	FDA UDI	Class II	Unknown
Premium 6, D2 / L18, CE	66006958	FDA UDI	Class II	Unknown
Artic	66080268	FDA UDI	Class II	Active
Delara	66071196	FDA UDI	Class II	Active
Mondial 6, A1 / S443, CE	66016857	FDA UDI	Class II	Active
Premium 8, D3 / XS, CE	66007297	FDA UDI	Class II	Unknown
Mondial 8, B2 / 32 U, CE	66802144	FDA UDI	Class II	Active
Mondial 6, D3 / S502, CE	66975640	FDA UDI	Class II	Active
Mondial 6, BL3 / T477, CE	66801064	FDA UDI	Class II	Active
Signum composite flow	66049060	FDA UDI	Class II	Active
VENUS Diamond FLOW	66100268	FDA UDI	Class II	Active
Mondial 6i, B2 / L24, CE	66970611	FDA UDI	Class II	Active
Artic digital 6, A2 / L55D, CE	66983021	FDA UDI	Class II	Active
Artic digital 6, A1 / R20D, CE	66983001	FDA UDI	Class II	Active
Mondial 6, B1 / L315, CE	66017001	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