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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 119 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8i, A2 / XSL, CE	66970863	FDA UDI	Class II	Active
Artic digital 6, D3 / L55D, CE	66983175	FDA UDI	Class II	Active
Basic 6, C1 / L05, CE	56739138	FDA UDI	Class II	Unknown
Basic 6, B4 / A13, CE	56739057	FDA UDI	Class II	Unknown
Mondial 6, C4 / L373, CE	66017202	FDA UDI	Class II	Active
Mondial 6, C3 / S451, CE	66975615	FDA UDI	Class II	Active
Mondial 6i DS, A1 / R2, CE	66986219	FDA UDI	Class II	Unknown
Mondial 6, A3 / S451, CE	66975527	FDA UDI	Class II	Active
Mondial 8i, D2 / 33L, CE	66973907	FDA UDI	Class II	Active
Delara	66071687	FDA UDI	Class II	Active
Artic 6, D2 / L 40, CE	66014106	FDA UDI	Class II	Active
HeraCeram Pastenopaker PO B2, 2ml	66003350	FDA UDI	Class II	Unknown
Artic 8, C4 / 20 degree - 30 U, CE	66014123	FDA UDI	Class II	Active
Mondial 6, B3 / S451, CE	66975567	FDA UDI	Class II	Active
Mondial 8 DS, A3.5 / 35L, CE	66986652	FDA UDI	Class II	Unknown
Mondial 6, C4 / L341, CE	66017199	FDA UDI	Class II	Active
Mondial 8i, A1 / 35 U, CE	66973788	FDA UDI	Class II	Active
Artic	66080567	FDA UDI	Class II	Active
Charisma	66000115	FDA UDI	Class II	Active
FLEXITIME DYNAMIX MONO REFILL(1X2X380ml)	40003990	FDA UDI	Class II	Active
VENUS Diamond FLOW SYR 1 x 1, 8G - Base	66041052	FDA UDI	Class II	Active
Flexitime Easy Putty 1 X 600 Ml	66002103	FDA UDI	Class II	Active
Dima	66081677	FDA UDI	Class II	Active
Mondial 8i, D2 / XS, CE	66970974	FDA UDI	Class II	Active
Artic 8, B1 / 20 degree - 32 U, CE	66012949	FDA UDI	Class II	Active
Basic 6, A2 / L04, CE	56739114	FDA UDI	Class II	Unknown
Basic 6, A2 / A13, CE	56739050	FDA UDI	Class II	Unknown
Premium 6, C1 / S2, CE	66007100	FDA UDI	Class II	Unknown
Mondial 6i DS, A3 / R2, CE	66986263	FDA UDI	Class II	Unknown
Dima	66081674	FDA UDI	Class II	Active
Flexitime Fast&Scan Easy Put&Flow Trial	66045791	FDA UDI	Class II	Unknown
Mondial 6 DS, B1 / O510, CE	66985753	FDA UDI	Class II	Unknown
Artic 8, C2 / 20 degree - 32 L, CE	66012958	FDA UDI	Class II	Active
Artic 6, B3 / T 10, CE	66014002	FDA UDI	Class II	Active
Artic 8 Posteriors	66015581	FDA UDI	Class II	Active
Artic digital 6, BL3 / T15D, CE	66080617	FDA UDI	Class II	Active
Cutter Hardener Universal Plus Paste	66037444	FDA UDI	Class II	Active
Delara	66071407	FDA UDI	Class II	Active
Delara	66071164	FDA UDI	Class II	Active
Artic digital 6, C2 / L05D, CE	66080493	FDA UDI	Class II	Active
Mondial 6i, BL2 / R2, CE	66970656	FDA UDI	Class II	Active
Artic	66080763	FDA UDI	Class II	Active
Mondial 8i, BL2 / XS, CE	66970926	FDA UDI	Class II	Active
Dima	66081671	FDA UDI	Class II	Active
Mondial 8i DS, A2 / 33L, CE	66986820	FDA UDI	Class II	Unknown
Mondial 8i, C3 / S, CE	66970960	FDA UDI	Class II	Active
Artic	66080341	FDA UDI	Class II	Active
Mondial 6, C4 / R449, CE	66017181	FDA UDI	Class II	Active
Artic 8, B1 / 30 degree - 30 L, CE	66037026	FDA UDI	Class II	Active
Mondial 6, BL1 / L373, CE	66801015	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