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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 93 of 123

Device	Model / Reference	Registries	Class	Status
Artic	66080496	FDA UDI	Class II	Active
Artic digital 6, C2 / T20D, CE	66080486	FDA UDI	Class II	Active
Mondial 8i DS, A2 / 37 U, CE	66986823	FDA UDI	Class II	Unknown
Mondial 8i DS, A3 / 37L, CE	66986840	FDA UDI	Class II	Unknown
Artic 8, C4 / 0 degree - 32 U, CE	66015221	FDA UDI	Class II	Active
Artic 8, D2 / 20 degree - 30 U, CE	66014124	FDA UDI	Class II	Active
Mondial 8 DS, A2 / 35 U, CE	66986631	FDA UDI	Class II	Unknown
Delara	66071249	FDA UDI	Class II	Active
Delara	66071168	FDA UDI	Class II	Active
Basic 6, C4 / U04, CE	56739301	FDA UDI	Class II	Unknown
Dima	66087416	FDA UDI	Class II	Active
Premium 6, B4 / L20, CE	66006969	FDA UDI	Class II	Unknown
Mondial 6, A1 / L384, CE	66016868	FDA UDI	Class II	Active
Artic	66080527	FDA UDI	Class II	Active
Delara	66071617	FDA UDI	Class II	Active
Delara	66071374	FDA UDI	Class II	Active
Delara	66071685	FDA UDI	Class II	Active
Premium 6, C4 / L14, CE	66006925	FDA UDI	Class II	Unknown
Delara	66071418	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 2x10x0, 25G C2	66039018	FDA UDI	Class II	Active
Artic 6, B3 / T 15, CE	66014961	FDA UDI	Class II	Active
Signum composite	66020024	FDA UDI	Class II	Active
HeraCeram Transpa Clear, 20g	66003412	FDA UDI	Class II	Unknown
Artic digital 8, D2 / 20 degrees-30LD, CE	66080771	FDA UDI	Class II	Active
Artic digital 6, A2 / L05D, CE	66080295	FDA UDI	Class II	Active
Artic digital 6, D3 / S30D, CE	66983169	FDA UDI	Class II	Active
Mondial 6i, C4 / S2, CE	66970776	FDA UDI	Class II	Active
Mondial 8i, A1 / SL, CE	66970857	FDA UDI	Class II	Active
Artic digital 6, B4 / L55D, CE	66983098	FDA UDI	Class II	Active
Mondial 8i, C1 / L, CE	66970948	FDA UDI	Class II	Active
Mondial 8i, D3 / XS, CE	66970982	FDA UDI	Class II	Active
Artic	66080616	FDA UDI	Class II	Active
Delara	66071625	FDA UDI	Class II	Active
Activator Universal Plus Paste 60ml	66037443	FDA UDI	Class II	Unknown
Mondial 8, C4 / 32L, CE	66802181	FDA UDI	Class II	Active
Mondial 8, B4 / 33 U, CE	66017375	FDA UDI	Class II	Active
Basic 8, A3 / FO, CE	56739595	FDA UDI	Class II	Unknown
Mondial 6, D3 / L369, CE	66017257	FDA UDI	Class II	Active
Mondial 8, D3 / 33L, CE	66017436	FDA UDI	Class II	Active
Premium 8, A1 / SL, CE	66007267	FDA UDI	Class II	Unknown
Mondial 6i DS, A2 / R2, CE	66986241	FDA UDI	Class II	Unknown
Artic 6, C2 / T 10, CE	66012846	FDA UDI	Class II	Active
Premium 6, A4 / S2, CE	66007095	FDA UDI	Class II	Unknown
Mondial 8i, BL2 / L, CE	66970932	FDA UDI	Class II	Active
Mondial 6i, B3 / T6, CE	66970618	FDA UDI	Class II	Active
Artic digital 6, C1 / T30D, CE	66983116	FDA UDI	Class II	Active
Mondial 6i, D2 / L16, CE	66970804	FDA UDI	Class II	Active
Mondial 6i, B4 / O4, CE	66970642	FDA UDI	Class II	Active
Artic digital 6, B2 / TO05D, CE	66080401	FDA UDI	Class II	Active
Artic	66080320	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