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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 17 of 123

Device	Model / Reference	Registries	Class	Status
Artic digital 6, C4 / R40D, CE	66983146	FDA UDI	Class II	Active
Mondial 6i, BL2 / L16, CE	66970672	FDA UDI	Class II	Active
Mondial 8, D4 / 31L, CE	66017444	FDA UDI	Class II	Active
Artic 6, A1 / TO 10, CE	66014852	FDA UDI	Class II	Active
Mondial 6, C2 / S445, CE	66017139	FDA UDI	Class II	Active
Artic	66080343	FDA UDI	Class II	Active
Ibond Self Etch Bottle Refill	66046242	FDA UDI	Class II	Unknown
Mondial 8i, B2 / SL, CE	66970905	FDA UDI	Class II	Active
Signum liquid	64714198	FDA UDI	Class II	Active
Mondial 6i, A3 / S8, CE	66970515	FDA UDI	Class II	Active
Mondial 6, B3 / O525, CE	66017053	FDA UDI	Class II	Active
Premium 6, D4 / R6, CE	66007090	FDA UDI	Class II	Unknown
Premium 8, A2 / S, CE	66007252	FDA UDI	Class II	Unknown
Venus Pearl	66081836	FDA UDI	Class II	Active
IBOND UNIVERSAL BOTTLE REFILL 1x4ml	66061411	FDA UDI	Class II	Active
Mondial 6, B3 / O510, CE	66017052	FDA UDI	Class II	Active
Artic 6, A1 / T 10, CE	66012840	FDA UDI	Class II	Active
Mondial 6i, B3 / R4, CE	66970613	FDA UDI	Class II	Active
HC-Zirkonia Schultermasse HM3, 20g	66020264	FDA UDI	Class II	Unknown
Artic 6, A4 / O 20, CE	66014046	FDA UDI	Class II	Active
Artic 8, D2 / 0 degree - 32 U, CE	66015231	FDA UDI	Class II	Active
Mondial 6, B2 / L331, CE	66017030	FDA UDI	Class II	Active
Basic 6, A4 / L01, CE	56739069	FDA UDI	Class II	Unknown
Artic digital 6, C1 / L25D, CE	66983119	FDA UDI	Class II	Active
Artic digital 6, A3.5 / S40D, CE	66983038	FDA UDI	Class II	Active
Mondial 6i, C1 / R4, CE	66970701	FDA UDI	Class II	Active
Mondial 6 DS, A3.5 / R455, CE	66985686	FDA UDI	Class II	Unknown
HeraCeram Dentin DC2, 20g	66003386	FDA UDI	Class II	Unknown
Artic 6, D2 / L 10, CE	66014079	FDA UDI	Class II	Active
Durafill VS	66002499	FDA UDI	Class II	Active
Artic	66080570	FDA UDI	Class II	Active
Artic digital 8, C3 / 20 degree-34LD, CE	66983262	FDA UDI	Class II	Active
Artic 8, B2 / 10 degree - 32 U, CE	66015165	FDA UDI	Class II	Active
Artic 6, D3 / L 05, CE	66015078	FDA UDI	Class II	Active
Premium 8, B4 / LL, CE	66007211	FDA UDI	Class II	Unknown
Mondial 6i, D4 / L16, CE	66970848	FDA UDI	Class II	Active
Gluma Comfort Bond+desensitizer 1 X 4 Ml	66001710	FDA UDI	Class II	Active
Basic 6, A1 / U04, CE	56739289	FDA UDI	Class II	Unknown
Delara	66071509	FDA UDI	Class II	Active
Artic 6, A3 / L 55, CE	66014890	FDA UDI	Class II	Active
Artic 8, A3.5 / 10 degree - 32 L, CE	66015136	FDA UDI	Class II	Active
Artic	66080608	FDA UDI	Class II	Active
Artic	66080409	FDA UDI	Class II	Active
HC-Zirkonia Dentin DC1, 20g	66020197	FDA UDI	Class II	Unknown
Premium 8, D2 / M, CE	66007232	FDA UDI	Class II	Unknown
Mondial 6, B3 / O444, CE	66017050	FDA UDI	Class II	Active
Artic 8, BL3 / 20 degree - 34 U, CE	66970440	FDA UDI	Class II	Active
Mondial 6i, C1 / R2, CE	66970700	FDA UDI	Class II	Active
HeraCeram Dentin DC1, 20g	66003384	FDA UDI	Class II	Unknown
Mondial 6, B1 / L384, CE	66017009	FDA UDI	Class II	Active

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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