Is this your brand? Sign in to claim ownership.

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 94 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 6i, A3 / L14, CE	66970517	FDA UDI	Class II	Active
Delara	66071201	FDA UDI	Class II	Active
Premium 6, C1 / S4, CE	66007116	FDA UDI	Class II	Unknown
Artic 6, A4 / L 50, CE	66014109	FDA UDI	Class II	Active
Basic 8, B3 / BU, CE	56739424	FDA UDI	Class II	Unknown
Basic 6, B2 / U07, CE	56739343	FDA UDI	Class II	Unknown
Mondial 6, C2 / T450, CE	66017130	FDA UDI	Class II	Active
Artic 6, B3 / L 30, CE	66014092	FDA UDI	Class II	Active
Premium 8, B1 / XS, CE	66007288	FDA UDI	Class II	Unknown
Artic digital 8, D2 / 10 degrees-32LD, CE	66080769	FDA UDI	Class II	Active
Artic 6, C4 / O 10, CE	66014042	FDA UDI	Class II	Active
Signum composite	66020023	FDA UDI	Class II	Active
Mondial 6, A1 / S550, CE	66975513	FDA UDI	Class II	Active
Mondial 8, B4 / 29L, CE	66017372	FDA UDI	Class II	Active
Mondial 6, C4 / R483, CE	66017183	FDA UDI	Class II	Active
Artic 6, A2 / TO 40, CE	66012890	FDA UDI	Class II	Active
Mondial 6i, C3 / O6, CE	66970753	FDA UDI	Class II	Active
Premium 8, A2 / LL, CE	66007204	FDA UDI	Class II	Unknown
Premium 6, A1 / S6, CE	66007123	FDA UDI	Class II	Unknown
Basic 8, A3.5 / HO, CE	56739532	FDA UDI	Class II	Unknown
Artic 8, A3 / 20 degree - 34 U, CE	66012961	FDA UDI	Class II	Active
Mondial 8, BL2 / 29L, CE	66801115	FDA UDI	Class II	Active
Mondial 6, BL3 / O525, CE	66801051	FDA UDI	Class II	Active
Artic 8, BL3 / 20 degree - 36 U, CE	66970450	FDA UDI	Class II	Active
Basic 6, B2 / P22, CE	56739215	FDA UDI	Class II	Unknown
Basic 6, B2 / L06, CE	56739151	FDA UDI	Class II	Unknown
Premium 8, A3 / XSL, CE	66007301	FDA UDI	Class II	Unknown
Mondial 8i, C4 / 33 U, CE	66973898	FDA UDI	Class II	Active
Mondial Standard Asst-8 drawer	66031206	FDA UDI	Class II	Unknown
Venus Pearl	66048199	FDA UDI	Class II	Active
Artic digital 6, D4 / TO05D, CE	66080599	FDA UDI	Class II	Active
Signum Opaque F	66020082	FDA UDI	Class II	Active
Artic 6, D2 / T 10, CE	66014007	FDA UDI	Class II	Active
Basic 6, B2 / P21, CE	56739199	FDA UDI	Class II	Unknown
Mondial 8i, C3 / 37L, CE	66973895	FDA UDI	Class II	Active
Basic 8, C2 / CU, CE	56739459	FDA UDI	Class II	Unknown
Delara	66071604	FDA UDI	Class II	Active
Delara	66071280	FDA UDI	Class II	Active
Premium 8, B4 / L, CE	66007195	FDA UDI	Class II	Unknown
Mondial 6, B4 / L398, CE	66017094	FDA UDI	Class II	Active
Basic 6, C4 / P20, CE	56739189	FDA UDI	Class II	Unknown
Cara	66088930	FDA UDI	Class II	Active
Premium 6, D3 / R2, CE	66007057	FDA UDI	Class II	Unknown
Artic	66080576	FDA UDI	Class II	Active
Basic 8, A3 / DU, CE	56739483	FDA UDI	Class II	Unknown
Artic 8, BL3 / 10 degree - 32 U, CE	66970448	FDA UDI	Class II	Active
Mondial 8i, D2 / S, CE	66970976	FDA UDI	Class II	Active
Basic 6, B3 / U06, CE	56739328	FDA UDI	Class II	Unknown
Basic 6, B2 / U01, CE	56739247	FDA UDI	Class II	Unknown
Mondial 8i, C1 / LL, CE	66970949	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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