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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 12 of 123

Device	Model / Reference	Registries	Class	Status
VENUS DIAMOND PLT REFILL 1x10x0, 25G YO	66039030	FDA UDI	Class II	Active
VENUS FLOW SYR 1 x 1, 8G - SB1	66014571	FDA UDI	Class II	Active
Artic 6, C3 / TO 40, CE	66014068	FDA UDI	Class II	Active
HeraCeram Dentin DA1, 20g	66003366	FDA UDI	Class II	Unknown
Charisma	66000091	FDA UDI	Class II	Active
Venus Diamond	66098275	FDA UDI	Class II	Active
Flexitime	66099318	FDA UDI	Class II	Active
Artic 6, B1 / L 55, CE	66014938	FDA UDI	Class II	Active
Artic 6, A1 / L 45, CE	66014857	FDA UDI	Class II	Active
Artic 6, B3 / S 10, CE	66013966	FDA UDI	Class II	Active
Premium 6, B2 / L14, CE	66006919	FDA UDI	Class II	Unknown
Mondial 6, A1 / R455, CE	66016845	FDA UDI	Class II	Active
VENUS DIAMOND SYRINGE REFILL 1x4G CO	66035492	FDA UDI	Class II	Active
Mondial 6, B2 / L362, CE	66017032	FDA UDI	Class II	Active
Artic 8, C4 / 0 degree - 30 L, CE	66015220	FDA UDI	Class II	Active
Mondial 6i, A2 / L18, CE	66970497	FDA UDI	Class II	Active
Mondial 8, B4 / 31 U, CE	66017373	FDA UDI	Class II	Active
Mondial 6i, BL3 / L14, CE	66970693	FDA UDI	Class II	Active
Artic digital 6, D3 / R30D, CE	66983167	FDA UDI	Class II	Active
Delara	66071478	FDA UDI	Class II	Active
Artic	66080388	FDA UDI	Class II	Active
Mondial 8i, C1 / XSL, CE	66970943	FDA UDI	Class II	Active
Mondial 6 DS, A3 / T442, CE	66985662	FDA UDI	Class II	Unknown
Mondial 6, D3 / L341, CE	66017255	FDA UDI	Class II	Active
Artic 8, B2 / 30 degree - 34 L, CE	66037036	FDA UDI	Class II	Active
Artic digital 8, B4 / 20 degree-32 UD, CE	66983235	FDA UDI	Class II	Active
Delara	66071414	FDA UDI	Class II	Active
Mondial 6, C2 / L378, CE	66017147	FDA UDI	Class II	Active
Artic	66080520	FDA UDI	Class II	Active
Artic 6, A1 / T 30, CE	66012854	FDA UDI	Class II	Active
Mondial 6, A4 / L398, CE	66016982	FDA UDI	Class II	Active
PALA cre-active, black, 3 g	66033462	FDA UDI	Class II	Active
Mondial 8, B1 / 31 U, CE	66017343	FDA UDI	Class II	Active
Mondial 8, D2 / 31L, CE	66017424	FDA UDI	Class II	Active
Mondial 6, A1 / O457, CE	66016854	FDA UDI	Class II	Active
Delara	66071323	FDA UDI	Class II	Active
Delara	66071242	FDA UDI	Class II	Active
Mondial 8i, A1 / ML, CE	66970859	FDA UDI	Class II	Active
Premium 8, C2 / XSL, CE	66007309	FDA UDI	Class II	Unknown
Mondial 6, D2 / T440, CE	66975635	FDA UDI	Class II	Active
Mondial 6i, B4 / R6, CE	66970636	FDA UDI	Class II	Active
Mondial 6i, C1 / L12, CE	66970714	FDA UDI	Class II	Active
Artic 6, A2 / S 40, CE	66012834	FDA UDI	Class II	Active
Mondial 8i, C2 / 31 U, CE	66973880	FDA UDI	Class II	Active
Basic 6, B1 / P20, CE	56739182	FDA UDI	Class II	Unknown
Mondial 6i DS, A3 / L18, CE	66986280	FDA UDI	Class II	Unknown
Mondial 6, BL1 / O457, CE	66800993	FDA UDI	Class II	Unknown
Basic 6, C4 / L01, CE	56739077	FDA UDI	Class II	Unknown
Xantasil	66079933	FDA UDI	Class II	Unknown
Basic 6, D2 / L02, CE	56739094	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