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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 115 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 6i, A4 / S6, CE	66970558	FDA UDI	Class II	Active
Artic 6 living Mould Chart A1	40005512	FDA UDI	Class II	Active
Mondial 6i, B1 / T2, CE	66970572	FDA UDI	Class II	Active
Mondial 6i, A2 / S4, CE	66970491	FDA UDI	Class II	Active
Mondial 6i, C3 / O2, CE	66970751	FDA UDI	Class II	Active
Artic 6, C3 / L 20, CE	66014086	FDA UDI	Class II	Active
Sopira Citoject Plastic Sleeve 1.8ml 1pc	66005419	FDA UDI	Class II	Active
Artic 6, D2 / L 45, CE	66015065	FDA UDI	Class II	Active
Artic 6, B4 / L 30, CE	66014093	FDA UDI	Class II	Active
VENUS Diamond FLOW SYR 1 x 1, 8G - CL	66040364	FDA UDI	Class II	Active
Artic 6, A2 / S 30, CE	66012827	FDA UDI	Class II	Active
HC-Zirkonia Opaltranspa OT1, 100g	66042425	FDA UDI	Class II	Unknown
Mondial 8, A3.5 / 33L, CE	66017326	FDA UDI	Class II	Active
PALA cre-active (assortment)	66033445	FDA UDI	Class II	Active
Mondial 6, D3 / R410, CE	66017235	FDA UDI	Class II	Active
Premium 8, B1 / SL, CE	66007272	FDA UDI	Class II	Unknown
Basic 8, D4 / BU, CE	56739432	FDA UDI	Class II	Unknown
Basic 8, C3 / HO, CE	56739540	FDA UDI	Class II	Unknown
Artic 6, BL3 / TO 40, CE	66970414	FDA UDI	Class II	Active
iBOND ETCH 35 GEL 2 x 2, 5 ML	66039862	FDA UDI	Class II	Active
Mondial 6, B2 / T477, CE	66017020	FDA UDI	Class II	Active
Mondial 8i, C4 / 31L, CE	66973897	FDA UDI	Class II	Active
Mondial 6, BL2 / T450, CE	66801034	FDA UDI	Class II	Active
Mondial 8, BL3 / 37 U, CE	66801132	FDA UDI	Class II	Active
Mondial 8i, B4 / M, CE	66970922	FDA UDI	Class II	Active
Mondial 8i, A3.5 / M, CE	66970882	FDA UDI	Class II	Active
Artic	66080351	FDA UDI	Class II	Active
Artic 8, D3 / 30 degree - 32 L, CE	66037082	FDA UDI	Class II	Active
Mondial 6, B2 / S443, CE	66017026	FDA UDI	Class II	Active
Mondial 6, B3 / R483, CE	66017043	FDA UDI	Class II	Active
Premium 8, B3 / ML, CE	66007242	FDA UDI	Class II	Unknown
Mondial 8, A3 / 37L, CE	66017320	FDA UDI	Class II	Active
Artic 8, A4 / 30 degree - 30 L, CE	66037020	FDA UDI	Class II	Active
Mondial 6i, A3 / R8, CE	66970505	FDA UDI	Class II	Active
Flexitime Heavy Tray 1x(2 X 50 Ml)	66002193	FDA UDI	Class II	Unknown
Artic digital 6, A2 / L25D, CE	66983020	FDA UDI	Class II	Active
Premium 8, D3 / L, CE	66007201	FDA UDI	Class II	Unknown
Mondial 8 DS, A3.5 / 31 U, CE	66986647	FDA UDI	Class II	Unknown
Artic digital 6, B2 / T20D, CE	66080398	FDA UDI	Class II	Active
Delara	66071667	FDA UDI	Class II	Active
Artic	66080594	FDA UDI	Class II	Active
Artic 8, D4 / 30 degree - 32 U, CE	66037087	FDA UDI	Class II	Active
Delara	66071448	FDA UDI	Class II	Active
Artic digital 6, B1 / T15D, CE	66080375	FDA UDI	Class II	Active
Artic digital 6, BL3 / L05D, CE	66080625	FDA UDI	Class II	Active
Artic digital 8, C4 / 20 degree-32LD, CE	66983266	FDA UDI	Class II	Active
Mondial 8i DS, A2 / 31L, CE	66986818	FDA UDI	Class II	Unknown
Basic 8, D2 / GO, CE	56739510	FDA UDI	Class II	Unknown
Artic 6, BL3 / R 20, CE	66970421	FDA UDI	Class II	Active
Basic 6, C2 / A11, CE	56739027	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