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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 1 of 123

Device	Model / Reference	Registries	Class	Status
Artic 6, A1 / S 30, CE	66012826	FDA UDI	Class II	Active
Premium 6, A2 / T4, CE	66007156	FDA UDI	Class II	Unknown
HC-Zirkonia Zr-Adhesive, neutral 3 ml	66039940	FDA UDI	Class II	Unknown
VENUS Diamond FLOW	66100274	FDA UDI	Class II	Active
Mondial 6, C1 / R520, CE	66975598	FDA UDI	Class II	Active
Signum Opaque F	66020074	FDA UDI	Class II	Active
Mondial 6, B3 / L398, CE	66017066	FDA UDI	Class II	Active
Premium 8, D4 / SL, CE	66007282	FDA UDI	Class II	Unknown
Mondial 6, BL1 / T442, CE	66801005	FDA UDI	Class II	Unknown
Artic digital 8, B1 / 10 degrees-32 UD, CE	66080688	FDA UDI	Class II	Active
Artic 6, D2 / O 20, CE	66014052	FDA UDI	Class II	Active
HeraCeram Pastenopaker bleach, 2ml	66003360	FDA UDI	Class II	Unknown
Basic 6, B1 / U05, CE	56739310	FDA UDI	Class II	Unknown
Delara	66071289	FDA UDI	Class II	Active
Mondial 6, A3.5 / O444, CE	66016938	FDA UDI	Class II	Active
Artic digital 8, A1 / 20 degree-32LD, CE	66983188	FDA UDI	Class II	Active
Mondial 8i, A3 / L, CE	66970876	FDA UDI	Class II	Active
Provil Novo P Fast 1x500	50035415	FDA UDI	Class II	Unknown
Delara	66071624	FDA UDI	Class II	Active
Signum matrix	66019703	FDA UDI	Class II	Active
Mondial 6, A1 / O525, CE	66016856	FDA UDI	Class II	Active
Delara	66071516	FDA UDI	Class II	Active
Delara	66071354	FDA UDI	Class II	Active
Artic 6, D2 / T 30, CE	66014025	FDA UDI	Class II	Active
Mondial 6 DS, A1 / R449, CE	66985577	FDA UDI	Class II	Unknown
Mondial 6, A4 / R455, CE	66016958	FDA UDI	Class II	Active
VENUS DIAMOND SYRINGE REFILL 1x4G OMC	66046736	FDA UDI	Class II	Active
Mondial 6, C4 / T452, CE	66975628	FDA UDI	Class II	Active
Mondial 6, A4 / T440, CE	66975547	FDA UDI	Class II	Active
Mondial 6 DS, A2 / R483, CE	66985615	FDA UDI	Class II	Unknown
Delara	66071185	FDA UDI	Class II	Active
Mondial 6, A3.5 / S443, CE	66016942	FDA UDI	Class II	Active
Delara	66071391	FDA UDI	Class II	Active
Artic 8, C2 / 30 degree - 32 U, CE	66037057	FDA UDI	Class II	Active
Artic 6, A2 / S 05, CE	66014863	FDA UDI	Class II	Active
Signum metal bond	66033915	FDA UDI	Class II	Active
Premium 6, A1 / S2, CE	66007091	FDA UDI	Class II	Unknown
Mondial 8i, A3.5 / XSL, CE	66970879	FDA UDI	Class II	Active
Translux® 2wave®	66055013	FDA UDI	Class II	Unknown
Charisma	66000117	FDA UDI	Class II	Active
Mondial 6i, D2 / L14, CE	66970803	FDA UDI	Class II	Active
Delara	66071269	FDA UDI	Class II	Active
Artic 6, B4 / R 40, CE	66014974	FDA UDI	Class II	Active
Artic 8, A3 / 30 degree - 30 U, CE	66037007	FDA UDI	Class II	Active
Premium 8, BL3 / XSL, CE	66803001	FDA UDI	Class II	Unknown
Artic	66080277	FDA UDI	Class II	Active
Mondial 6, A2 / R420, CE	66016871	FDA UDI	Class II	Active
Artic 6, B2 / TO 05, CE	66014947	FDA UDI	Class II	Active
Artic 6, A3.5 / O 20, CE	66012878	FDA UDI	Class II	Active
Delara	66071580	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