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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 85 of 123

Device	Model / Reference	Registries	Class	Status
Basic 6, B3 / U04, CE	56739296	FDA UDI	Class II	Unknown
Artic digital 6, B3 / L55D, CE	66983087	FDA UDI	Class II	Active
Mondial 6, D3 / O525, CE	66017249	FDA UDI	Class II	Active
Artic 6, A4 / T 35, CE	66014914	FDA UDI	Class II	Active
Mondial 6i, C1 / L19, CE	66970718	FDA UDI	Class II	Active
Mondial 6i, B4 / R8, CE	66970637	FDA UDI	Class II	Active
Mondial 6i, A1 / L18, CE	66970475	FDA UDI	Class II	Active
Artic digital 6, C2 / TO20D, CE	66983128	FDA UDI	Class II	Active
Basic 8, C2 / DO, CE	56739475	FDA UDI	Class II	Unknown
Artic digital 6, D2 / TO10D, CE	66080556	FDA UDI	Class II	Active
Artic	66080394	FDA UDI	Class II	Active
Artic	66080735	FDA UDI	Class II	Active
Venus Pearl	66048173	FDA UDI	Class II	Active
Premium 6, A3.5 / S2, CE	66007094	FDA UDI	Class II	Unknown
Artic 8, BL3 / 30 degree - 34 L, CE	66970457	FDA UDI	Class II	Active
Basic 8, D2 / EU, CE	56739590	FDA UDI	Class II	Unknown
Artic digital 6, A4 / O30D, CE	66983044	FDA UDI	Class II	Active
Basic 6, D3 / P23, CE	56739239	FDA UDI	Class II	Unknown
Gluma Comfort Bond+desensitizer 3 X 4 Ml	66018222	FDA UDI	Class II	Active
Gluma Solid Bond Primer 4ml Fl	66000133	FDA UDI	Class II	Unknown
Provil Novo	65220733	FDA UDI	Class II	Unknown
Mondial 6, B2 / R449, CE	66017013	FDA UDI	Class II	Active
Basic 6, C3 / L06, CE	56739156	FDA UDI	Class II	Unknown
Mondial 6 DS, A3 / L315, CE	66985669	FDA UDI	Class II	Unknown
Artic digital 8, B1 / 10 degrees-30LD, CE	66080687	FDA UDI	Class II	Active
Flexitime Xtreme 2 Heavy Tray 6x50 Ml	66044885	FDA UDI	Class II	Active
Mondial 6 DS, B1 / R455, CE	66985758	FDA UDI	Class II	Unknown
Mondial 6, C1 / T515, CE	66017105	FDA UDI	Class II	Active
Basic living Mould Chart A3	50740009	FDA UDI	Class II	Active
Artic 6, C3 / R 20, CE	66015020	FDA UDI	Class II	Active
Mondial 8i, C3 / 35 U, CE	66973892	FDA UDI	Class II	Active
Mondial 6 DS, A3 / L398, CE	66985678	FDA UDI	Class II	Unknown
Delara	66071494	FDA UDI	Class II	Active
Artic	66080458	FDA UDI	Class II	Active
Artic	66080296	FDA UDI	Class II	Active
Mondial 8 DS, B1 / 33L, CE	66986670	FDA UDI	Class II	Unknown
Delara	66071497	FDA UDI	Class II	Active
Mondial 8 DS, B1 / 35 U, CE	66986671	FDA UDI	Class II	Unknown
Delara	66071592	FDA UDI	Class II	Active
Durafill VS	66000019	FDA UDI	Class II	Unknown
Mondial 6, A3.5 / L382, CE	66016952	FDA UDI	Class II	Active
Artic 6, A1 / T 15, CE	66014849	FDA UDI	Class II	Active
Dima	66077054	FDA UDI	Class II	Unknown
Mondial 6, B1 / T495, CE	66975557	FDA UDI	Class II	Active
Artic 6, A4 / L 40, CE	66014100	FDA UDI	Class II	Active
Artic 8, A4 / 0 degree - 32 U, CE	66015141	FDA UDI	Class II	Active
Mondial 6i, A3 / S4, CE	66970513	FDA UDI	Class II	Active
Artic 8, C4 / 20 degree - 30 L, CE	66014132	FDA UDI	Class II	Active
Mondial 8, D2 / 28L, CE	66802183	FDA UDI	Class II	Active
Mondial 6, B4 / L341, CE	66017087	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