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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 99 of 123

Device	Model / Reference	Registries	Class	Status
Premium 6, A2 / R6, CE	66007076	FDA UDI	Class II	Unknown
Mondial 6, D4 / R483, CE	66017267	FDA UDI	Class II	Active
Basic 8, D4 / HO, CE	56739544	FDA UDI	Class II	Unknown
Mondial 8, A3 / 33L, CE	66017316	FDA UDI	Class II	Active
Mondial 6i, D3 / L22, CE	66970830	FDA UDI	Class II	Active
Basic 6, C1 / U02, CE	56739266	FDA UDI	Class II	Unknown
Artic digital 8, D3 / 20 degree-36 UD, CE	66983281	FDA UDI	Class II	Active
Mondial 8i, A3 / 35 U, CE	66973804	FDA UDI	Class II	Active
Mondial 8, BL2 / 35 U, CE	66801120	FDA UDI	Class II	Active
Mondial 8i, C1 / XS, CE	66970942	FDA UDI	Class II	Active
Mondial 6i, A3.5 / R4, CE	66970525	FDA UDI	Class II	Active
Mondial 8 DS, B1 / 33 U, CE	66986669	FDA UDI	Class II	Unknown
Artic	66080502	FDA UDI	Class II	Active
Delara	66071511	FDA UDI	Class II	Active
Premium 6, C4 / S2, CE	66007103	FDA UDI	Class II	Unknown
HeraCeram Schneide S4, 20g	66003404	FDA UDI	Class II	Unknown
Artic 8, C2 / 0 degree - 30 L, CE	66015200	FDA UDI	Class II	Active
Delara	66071521	FDA UDI	Class II	Active
Artic digital 8, B3 / 20 degree-36LD, CE	66983234	FDA UDI	Class II	Active
Sopira Citoject Barr Ang 1.8ml/Inch La	66002394	FDA UDI	Class II	Active
Artic digital 8, B1 / 20 degree-36 UD, CE	66983221	FDA UDI	Class II	Active
Mondial 6, B2 / L378, CE	66017035	FDA UDI	Class II	Active
Delara	66071559	FDA UDI	Class II	Active
Mondial 6 DS, A3 / L362, CE	66985672	FDA UDI	Class II	Unknown
Artic	66080692	FDA UDI	Class II	Active
Premium 6, BL3 / L22, CE	66802965	FDA UDI	Class II	Unknown
Basic 6, B4 / L05, CE	56739137	FDA UDI	Class II	Unknown
Artic 8, C3 / 10 degree - 32 L, CE	66015216	FDA UDI	Class II	Active
Artic 6, A4 / L 20, CE	66014082	FDA UDI	Class II	Active
Delara	66071468	FDA UDI	Class II	Active
Mondial 8, C3 / 30L, CE	66802173	FDA UDI	Class II	Active
Mondial 8i, D4 / 37L, CE	66973927	FDA UDI	Class II	Active
Premium 8, A3.5 / S, CE	66007254	FDA UDI	Class II	Unknown
HC-Zirkonia Opalschneide OS1, 100g	66042422	FDA UDI	Class II	Unknown
Mondial 6, D2 / L398, CE	66017234	FDA UDI	Class II	Active
VENUS FLOW SYR ASSORTMENT 4 x 1, 8 G	66014561	FDA UDI	Class II	Unknown
Mondial 6, C2 / S502, CE	66975608	FDA UDI	Class II	Active
Premium 6, BL2 / O6, CE	66802938	FDA UDI	Class II	Unknown
Artic digital 6, C3 / R20D, CE	66983133	FDA UDI	Class II	Active
Mondial 8, B2 / 35 U, CE	66017357	FDA UDI	Class II	Active
Artic 6, BL3 / S 10, CE	66970403	FDA UDI	Class II	Active
Artic 6, A3 / O 20, CE	66012877	FDA UDI	Class II	Active
Artic 6, C4 / L 15, CE	66015047	FDA UDI	Class II	Active
Delara	66071221	FDA UDI	Class II	Active
Artic digital 6, C1 / R40D, CE	66983113	FDA UDI	Class II	Active
Durafill VS	66000025	FDA UDI	Class II	Active
Charisma	66000106	FDA UDI	Class II	Active
Mondial 6, D2 / L378, CE	66017231	FDA UDI	Class II	Active
Dima	66081670	FDA UDI	Class II	Active
Venus Pearl	66048150	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