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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 111 of 123

Device	Model / Reference	Registries	Class	Status
Premium 6, B2 / L12, CE	66006903	FDA UDI	Class II	Unknown
Artic 6, C3 / L 30, CE	66014095	FDA UDI	Class II	Active
Artic digital 8, B2 / 20 degree-32LD, CE	66983224	FDA UDI	Class II	Active
PalaXpress ultra, 500ml liquid	66034251	FDA UDI	Class II	Unknown
Mondial 6i, A2 / R2, CE	66970480	FDA UDI	Class II	Active
Mondial 8, A3 / 29L, CE	66017312	FDA UDI	Class II	Active
Premium 6, C2 / S6, CE	66007133	FDA UDI	Class II	Unknown
Mondial 6, C1 / L315, CE	66017113	FDA UDI	Class II	Active
Artic 8, A2 / 10 degree - 32 U, CE	66015115	FDA UDI	Class II	Active
Artic 8, D3 / 20 degree - 32 U, CE	66014143	FDA UDI	Class II	Active
HeraCeram Dentin DA3, 20g	66003370	FDA UDI	Class II	Unknown
Artic 8, A2 / 20 degree - 34 L, CE	66012967	FDA UDI	Class II	Active
Premium 6, D3 / L16, CE	66006943	FDA UDI	Class II	Unknown
Artic 6, C2 / S 40, CE	66012839	FDA UDI	Class II	Active
Basic 8, A3.5 / DU, CE	56739484	FDA UDI	Class II	Unknown
Artic 6, A3 / T 30, CE	66012856	FDA UDI	Class II	Active
Artic 6, A3.5 / S 30, CE	66012829	FDA UDI	Class II	Active
Premium 6, A4 / T4, CE	66007159	FDA UDI	Class II	Unknown
Delara	66071308	FDA UDI	Class II	Active
Artic 8, B2 / 20 degree - 36 L, CE	66015168	FDA UDI	Class II	Active
Mondial 6, D3 / R449, CE	66017237	FDA UDI	Class II	Active
Basic 6, D3 / L01, CE	56739079	FDA UDI	Class II	Unknown
Artic 8, D3 / 10 degree - 32 L, CE	66015246	FDA UDI	Class II	Active
Mondial 6, D2 / R410, CE	66017207	FDA UDI	Class II	Active
Mondial 6, D2 / S453, CE	66017224	FDA UDI	Class II	Active
Artic digital 6, A4 / L20D, CE	66983052	FDA UDI	Class II	Active
Premium 6, A3 / R2, CE	66007045	FDA UDI	Class II	Unknown
Artic 8, A2 / 20 degree - 36 L, CE	66015118	FDA UDI	Class II	Active
Artic 6, D2 / R 40, CE	66015054	FDA UDI	Class II	Active
Mondial 6, D2 / R483, CE	66017211	FDA UDI	Class II	Active
Basic 8, B1 / GO, CE	56739502	FDA UDI	Class II	Unknown
Mondial 8i, A1 / 33 U, CE	66973786	FDA UDI	Class II	Active
Mondial 8i DS, A1 / 33L, CE	66986804	FDA UDI	Class II	Unknown
Artic digital 6, A2 / T20D, CE	66080288	FDA UDI	Class II	Active
Artic	66080629	FDA UDI	Class II	Active
Artic digital 6, D2 / TO40D, CE	66080558	FDA UDI	Class II	Active
Artic digital 8, A2 / 10 degrees-30 UD, CE	66080646	FDA UDI	Class II	Active
Artic	66080484	FDA UDI	Class II	Active
Mondial 6, C4 / T435, CE	66975626	FDA UDI	Class II	Active
Delara	66071385	FDA UDI	Class II	Active
Artic digital 6, B1 / T20D, CE	66080376	FDA UDI	Class II	Active
Artic digital 6, BL3 / T35D, CE	66080619	FDA UDI	Class II	Active
Mondial 6i, BL3 / L12, CE	66970692	FDA UDI	Class II	Active
Mondial 6i, A1 / R4, CE	66970459	FDA UDI	Class II	Active
Basic 6, B4 / U06, CE	56739329	FDA UDI	Class II	Unknown
Artic digital 6, B2 / TO40D, CE	66080404	FDA UDI	Class II	Active
Delara	66071413	FDA UDI	Class II	Active
Artic digital 6, B3 / T35D, CE	66080421	FDA UDI	Class II	Active
Mondial 6, BL1 / T405, CE	66801004	FDA UDI	Class II	Unknown
Mondial 8, BL1 / 37 U, CE	66801112	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