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Sign in to claim this brandKulzer, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 4315 S. Lafayette Blvd., SOUTH BEND, IN, 46614
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1821514
- DUNS Number
- —
Catalogue (6131)
Page 122 of 123| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Artic 6, C4 / L 45, CE | 66015049 | FDA UDI | Class II | Active |
| Basic 8, C1 / BU, CE | 56739426 | FDA UDI | Class II | Unknown |
| Artic digital 6, A3 / O10D, CE | 66080302 | FDA UDI | Class II | Active |
| Artic digital 6, B3 / S30D, CE | 66983081 | FDA UDI | Class II | Active |
| Mondial 8, D2 / 29L, CE | 66017422 | FDA UDI | Class II | Active |
| Artic 6, A3.5 / TO 20, CE | 66014901 | FDA UDI | Class II | Active |
| Mondial 8i, C1 / ML, CE | 66970947 | FDA UDI | Class II | Active |
| Ibond Self Etch Single Dose Refill | 66046244 | FDA UDI | Class II | Unknown |
| Artic | 66080605 | FDA UDI | Class II | Active |
| Artic | 66080524 | FDA UDI | Class II | Active |
| Artic digital 6, B4 / T35D, CE | 66080443 | FDA UDI | Class II | Active |
| Artic | 66080362 | FDA UDI | Class II | Active |
| Venus Pearl PLT A2 500x0.2g Mail | 66053801 | FDA UDI | Class II | Unknown |
| Mondial 8, BL1 / 31L, CE | 66801107 | FDA UDI | Class II | Unknown |
| Artic | 66080541 | FDA UDI | Class II | Active |
| Mondial 6, BL2 / T477, CE | 66801036 | FDA UDI | Class II | Active |
| Delara | 66071631 | FDA UDI | Class II | Active |
| Mondial 6, C4 / T442, CE | 66017185 | FDA UDI | Class II | Active |
| Mondial 6, BL3 / T465, CE | 66801063 | FDA UDI | Class II | Active |
| Mondial 8i, BL3 / LL, CE | 66970941 | FDA UDI | Class II | Active |
| Mondial 6, BL1 / O525, CE | 66800995 | FDA UDI | Class II | Unknown |
| Artic digital 6, A1 / O30D, CE | 66983000 | FDA UDI | Class II | Active |
| Artic digital 8, B2 / 10 degrees-30 UD, CE | 66080696 | FDA UDI | Class II | Active |
| Ivory | 66076087 | FDA UDI | Class I | Unknown |
| Memoreg 2 3 X (2 X 50 Ml) | 66004965 | FDA UDI | Class II | Unknown |
| Basic 6, C4 / L02, CE | 56739093 | FDA UDI | Class II | Unknown |
| Artic 8 Living Mould Chart B1 | 40005511 | FDA UDI | Class II | Active |
| Flexitime Xtreme Correct Fl. Ref. 6x50ml | 66019688 | FDA UDI | Class II | Unknown |
| Artic 8, C1 / 20 degree - 36 U, CE | 66015197 | FDA UDI | Class II | Active |
| Mondial 6, B2 / T465, CE | 66017019 | FDA UDI | Class II | Active |
| Premium 6, D3 / S6, CE | 66007137 | FDA UDI | Class II | Unknown |
| Artic 8, B3 / 10 degree - 32 L, CE | 66015176 | FDA UDI | Class II | Active |
| Premium 6, A3.5 / T6, CE | 66007174 | FDA UDI | Class II | Unknown |
| Mondial 6i, C2 / O6, CE | 66970731 | FDA UDI | Class II | Active |
| Charisma ABC | 66064791 | FDA UDI | Class II | Active |
| Mondial 6i, B2 / R2, CE | 66970590 | FDA UDI | Class II | Active |
| Delara | 66071304 | FDA UDI | Class II | Active |
| Basic 6, A4 / L06, CE | 56739149 | FDA UDI | Class II | Unknown |
| Basic 8, B4 / BO, CE | 56739409 | FDA UDI | Class II | Unknown |
| Artic 8, C1 / 0 degree - 32 U, CE | 66015191 | FDA UDI | Class II | Active |
| Basic 8, D3 / GU, CE | 56739527 | FDA UDI | Class II | Unknown |
| Artic 8, B4 / 20 degree - 32 U, CE | 66014138 | FDA UDI | Class II | Active |
| HeraCeram Pastenopaker PO A2, 2ml | 66003345 | FDA UDI | Class II | Unknown |
| Palapress(r) Vario Resin | K902115 | FDA 510(k) | Class II | Active |
| dima Print Teeth & Temp | K233868 | FDA 510(k) | Class II | Active |
| Denthesive | K905302 | FDA 510(k) | Class II | Active |
| Retraxil | K243910 | FDA 510(k) | U | Active |
| Silicoater Md | K910719 | FDA 510(k) | Class II | Active |
| Kulzer Glas-Ionomer Cement | K892453 | FDA 510(k) | Class II | Active |
| Durafill Color Vs | K905131 | FDA 510(k) | 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