Kulzer, Inc.
Medical device manufacturer in South Bend, IN.
38510(k) clearances
0PMA approvals
0recalls
Device types
- EBF Material, Tooth Shade, Resin 19
- EBZ Activator, Ultraviolet, For Polymerization 3
- EBG Crown And Bridge, Temporary, Resin 3
- EBI Resin, Denture, Relining, Repairing, Rebasing 3
- EMA Cement, Dental 3
- EBH Material, Impression Tray, Resin 2
- EJJ Alloy, Amalgam 1
- ELW Material, Impression 1
- KLE Agent, Tooth Bonding, Resin 1
- EGD Wax, Dental, Intraoral 1
- MVL Cord, Retraction 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneEBF · Traditional | 03/11/2026SE |
| K254063 | iCEM Universal PlusEMA · Abbreviated | 12/19/2025SE |
| K243910 | RetraxilMVL · Traditional | 09/24/2025SE |
| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite…EBF · Traditional | 09/17/2024SE |
| K233868 | dima Print Teeth & TempEBG · Traditional | 05/23/2024SE |
| K230644 | Signum opaque FEBF · Traditional | 09/07/2023SE |
| K220605 | Venus Bulk Flow ONEEBF · Special | 04/21/2022SE |
| K905058 | Palavit LEBH · Traditional | 06/06/1991SE |
| K904928 | Palavit GLCEGD · Traditional | 06/06/1991SE |
| K910263 | CharismaEBF · Traditional | 06/03/1991SE |
| K910719 | Silicoater MDEMA · Traditional | 04/29/1991SE |
| K905131 | Durafill Color VSEBF · Traditional | 03/15/1991SE |
| K905302 | DenthesiveKLE · Traditional | 02/26/1991SE |
| K904555 | Durafill FlowEBF · Traditional | 11/13/1990SE |
| K903317 | Dentalon PlusEBG · Traditional | 08/13/1990SE |
| K902115 | Palapress(R) Vario ResinEBI · Traditional | 07/27/1990SE |
| K902350 | Palatray LC Resin Impression Tray MaterialEBH · Traditional | 07/26/1990SE |
| K901789 | Paladon(R) 65EBI · Traditional | 06/22/1990SE |
| K901697 | Silistor Ceramic and Resin Repair SystemEBF · Traditional | 06/15/1990SE |
| K901681 | Formasil(R)A Polyvinyl Siloxane LineELW · Traditional | 06/15/1990SE |
| K892453 | Kulzer Glas-Ionomer CementEMA · Traditional | 12/04/1989SE |
| K892455 | Kulzer Adhesive CementEBF · Traditional | 06/22/1989SE |
| K892454 | Kulzer Inlay SystemEBF · Traditional | 06/16/1989SE |
| K892452 | Palaseal(R)EBI · Traditional | 06/16/1989SE |
| K892456 | Kulzer Translux EcEBZ · Traditional | 06/14/1989SE |
| K875344 | Heraeus' Heragam 48, Non Gamma 2 Den. Amal. AlloyEJJ · Traditional | 03/18/1988SE |
| K862546 | Microfill PonticEBF · Traditional | 10/14/1986SE |
| K863315 | Multifil(R) VSEBF · Traditional | 09/22/1986SE |
| K863314 | Estilux(R) Posterior CEBF · Traditional | 09/22/1986SE |
| K850965 | Kulzer Dentin AdhesiveEBF · Traditional | 04/22/1985SE |
| K843823 | Translux CLEBZ · Traditional | 12/04/1984SE |
| K840176 | Estic MicrofillEBF · Traditional | 04/13/1984SE |
| K831215 | Dentacolor Light Curing Crown & BridgeEBF · Traditional | 09/12/1983SE |
| K831077 | DentalonEBG · Traditional | 09/12/1983SE |
| K813568 | Estilux Posterior XREBF · Traditional | 01/29/1982SE |
| K812889 | Estilux PosteriorEBF · Traditional | 11/17/1981SE |
| K811668 | Kulzer Translux Visible Light CuringEBZ · Traditional | 07/28/1981SE |
| K811669 | Durafill Microfill Restorative MaterialEBF · Traditional | 07/01/1981SE |