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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 83 of 123

Device	Model / Reference	Registries	Class	Status
Artic 8, C4 / 20 degree - 36 U, CE	66015227	FDA UDI	Class II	Active
Mondial 6, A1 / R483, CE	66016846	FDA UDI	Class II	Active
Artic 8, C4 / 30 degree - 32 U, CE	66037069	FDA UDI	Class II	Active
Artic 6, B3 / R 20, CE	66014956	FDA UDI	Class II	Active
Premium 6, A4 / R4, CE	66007063	FDA UDI	Class II	Unknown
Artic 6, D3 / L 55, CE	66015082	FDA UDI	Class II	Active
Flexitime Xtreme 2 Correct Flow 6 pc	66050334	FDA UDI	Class II	Active
Mondial 6, A1 / L362, CE	66016863	FDA UDI	Class II	Active
Basic 6, C2 / U06, CE	56739331	FDA UDI	Class II	Unknown
Dima	66081673	FDA UDI	Class II	Active
Delara	66071491	FDA UDI	Class II	Active
Artic 6, C1 / TO 05, CE	66014995	FDA UDI	Class II	Active
Charisma	66000087	FDA UDI	Class II	Active
Artic 6, C2 / R 30, CE	66015005	FDA UDI	Class II	Active
Artic 6, C4 / T 10, CE	66014006	FDA UDI	Class II	Active
Mondial 8, B1 / 29 U, CE	66017341	FDA UDI	Class II	Active
Basic 8, B4 / DO, CE	56739473	FDA UDI	Class II	Unknown
Basic 6, A2 / U03, CE	56739274	FDA UDI	Class II	Unknown
Basic 6, A1 / P21, CE	56739193	FDA UDI	Class II	Unknown
Mondial 6i, A3 / L18, CE	66970519	FDA UDI	Class II	Active
Basic 8, C1 / DU, CE	56739490	FDA UDI	Class II	Unknown
Delara	66071658	FDA UDI	Class II	Active
Mondial 6, B1 / R410, CE	66016983	FDA UDI	Class II	Active
Artic 6, C3 / L 40, CE	66014104	FDA UDI	Class II	Active
Mondial 8, A2 / 28 U, CE	66802110	FDA UDI	Class II	Active
Artic 6, D2 / L 20, CE	66014088	FDA UDI	Class II	Active
Artic 6, BL3 / L 55, CE	66970435	FDA UDI	Class II	Active
Artic digital 6, A1 / TO20D, CE	66983007	FDA UDI	Class II	Active
Artic digital 8, A2 / 20 degree-34LD, CE	66983196	FDA UDI	Class II	Active
Premium 6, C3 / S4, CE	66007118	FDA UDI	Class II	Unknown
Premium 6, C2 / O6, CE	66007037	FDA UDI	Class II	Unknown
HeraCeram Dentin DD2, 20g	66003392	FDA UDI	Class II	Unknown
Mondial 6i DS, A3 / O4, CE	66986271	FDA UDI	Class II	Unknown
Artic 6, A1 / L 20, CE	66012903	FDA UDI	Class II	Active
Premium 6, D2 / T2, CE	66007152	FDA UDI	Class II	Unknown
Premium 8, A3 / L, CE	66007189	FDA UDI	Class II	Unknown
Mondial 6i DS, A1 / O4, CE	66986227	FDA UDI	Class II	Unknown
Mondial 8i, D3 / 33L, CE	66973915	FDA UDI	Class II	Active
Mondial 8i, B4 / 33L, CE	66973851	FDA UDI	Class II	Active
Premium 8, D4 / ML, CE	66007250	FDA UDI	Class II	Unknown
iBOND Total Etch Bottle Assortment	66039866	FDA UDI	Class II	Unknown
Basic 6, A3.5 / U05, CE	56739308	FDA UDI	Class II	Unknown
Mondial 6 DS, A2 / T477, CE	66985630	FDA UDI	Class II	Unknown
Mondial 6, C3 / L315, CE	66017169	FDA UDI	Class II	Active
Mondial 8, B1 / 35L, CE	66017348	FDA UDI	Class II	Active
Mondial 6 DS, A1 / L378, CE	66985603	FDA UDI	Class II	Unknown
Mondial 6 DS, A3 / T477, CE	66985666	FDA UDI	Class II	Unknown
Dima	66087423	FDA UDI	Class II	Active
Premium 6, D3 / L18, CE	66006959	FDA UDI	Class II	Unknown
Venus Pearl	66081840	FDA UDI	Class II	Unknown

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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