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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 2 of 123

Device	Model / Reference	Registries	Class	Status
Artic digital 8, B1 / 20 degree-34LD, CE	66983220	FDA UDI	Class II	Active
Artic 8, A3.5 / 10 degree - 30 L, CE	66015134	FDA UDI	Class II	Active
Basic 8, B2 / BU, CE	56739423	FDA UDI	Class II	Unknown
Mondial 6i, D3 / L20, CE	66970829	FDA UDI	Class II	Active
Artic	66080329	FDA UDI	Class II	Active
Artic 8, D2 / 30 degree - 32 U, CE	66037075	FDA UDI	Class II	Active
Mondial 6, A3.5 / O510, CE	66016940	FDA UDI	Class II	Active
Artic	66080525	FDA UDI	Class II	Active
Mondial 6, A3 / R420, CE	66016900	FDA UDI	Class II	Active
Mondial 6, D3 / L384, CE	66017261	FDA UDI	Class II	Active
Basic 8, B2 / HO, CE	56739535	FDA UDI	Class II	Unknown
Premium 6, C2 / L14, CE	66006923	FDA UDI	Class II	Unknown
Provil Novo L. F Cd2 1x(2x50ml)	66008290	FDA UDI	Class II	Unknown
Artic digital 6, C4 / O10D, CE	66080522	FDA UDI	Class II	Active
Delara	66071612	FDA UDI	Class II	Active
Delara	66071180	FDA UDI	Class II	Active
Mondial 6, C1 / L362, CE	66017116	FDA UDI	Class II	Active
Premium 8, C4 / M, CE	66007231	FDA UDI	Class II	Unknown
Basic 6, C3 / U01, CE	56739252	FDA UDI	Class II	Unknown
Signum Opaque F	66020076	FDA UDI	Class II	Active
Artic digital 8, D4 / 10 degrees-30 UD, CE	66080786	FDA UDI	Class II	Active
Mondial 6, A2 / L373, CE	66016894	FDA UDI	Class II	Active
Delara	66071576	FDA UDI	Class II	Active
Delara	66071485	FDA UDI	Class II	Active
Mondial 8 DS, A3 / 35 U, CE	66986641	FDA UDI	Class II	Unknown
Mondial 8, C4 / 35L, CE	66017418	FDA UDI	Class II	Active
Mondial 8i, B4 / SL, CE	66970921	FDA UDI	Class II	Active
Premium 6, B1 / S6, CE	66007128	FDA UDI	Class II	Unknown
Artic 6, BL3 / S 35, CE	66970425	FDA UDI	Class II	Active
Artic 6, C2 / S 30, CE	66012832	FDA UDI	Class II	Active
Premium 6, B2 / R6, CE	66007081	FDA UDI	Class II	Unknown
Premium 8, C1 / S, CE	66007260	FDA UDI	Class II	Unknown
Basic 8, C3 / GO, CE	56739508	FDA UDI	Class II	Unknown
Basic 6, C1 / U07, CE	56739346	FDA UDI	Class II	Unknown
Artic 6, BL3 / T 30, CE	66970409	FDA UDI	Class II	Active
Artic 8, A4 / 20 degree - 36 L, CE	66015148	FDA UDI	Class II	Active
Artic 6, A1 / S 40, CE	66012833	FDA UDI	Class II	Active
Mondial 6, C2 / R455, CE	66017126	FDA UDI	Class II	Active
Premium 6, B3 / R6, CE	66007082	FDA UDI	Class II	Unknown
Mondial 6, B3 / L373, CE	66017062	FDA UDI	Class II	Active
Premium 8, C2 / S, CE	66007261	FDA UDI	Class II	Unknown
Mondial 6, C3 / T477, CE	66017160	FDA UDI	Class II	Active
Artic 8, C2 / 0 degree - 32 U, CE	66015201	FDA UDI	Class II	Active
Delara	66071648	FDA UDI	Class II	Active
Artic digital 6, C2 / T35D, CE	66080487	FDA UDI	Class II	Active
Delara	66071496	FDA UDI	Class II	Active
Artic	66080754	FDA UDI	Class II	Active
HeraCeram Enhancer EH grey, 20g	66033971	FDA UDI	Class II	Unknown
Artic digital 8, B1 / 20 degrees-30 UD, CE	66080690	FDA UDI	Class II	Active
Charisma ABC	66064775	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