Company ยท US
Kulzer, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2026. Name variants (Inc, Corp, punctuation) are merged.
38510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 19 |
| EBG | Crown And Bridge, Temporary, Resin | 3 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 3 |
| EBZ | Activator, Ultraviolet, For Polymerization | 3 |
| EMA | Cement, Dental | 3 |
| EBH | Material, Impression Tray, Resin | 2 |
| EGD | Wax, Dental, Intraoral | 1 |
| EJJ | Alloy, Amalgam | 1 |
| ELW | Material, Impression | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 |
| MVL | Cord, Retraction | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 11, 2026 | K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One Kulzer, LLC | EBF |
| Dec 19, 2025 | K254063 | iCEM Universal Plus Kulzer, LLC | EMA |
| Sep 24, 2025 | K243910 | Retraxil Kulzer, LLC | MVL |
| Sep 17, 2024 | K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum Kulzer, LLC | EBF |
| May 23, 2024 | K233868 | dima Print Teeth & Temp Kulzer, LLC | EBG |
| Sep 7, 2023 | K230644 | Signum opaque F Kulzer, LLC | EBF |
| Apr 21, 2022 | K220605 | Venus Bulk Flow ONE Kulzer, LLC | EBF |
| Jun 6, 1991 | K905058 | PALAVIT L Kulzer, Inc. | EBH |
| Jun 6, 1991 | K904928 | PALAVIT GLC Kulzer, Inc. | EGD |
| Jun 3, 1991 | K910263 | CHARISMA Kulzer, Inc. | EBF |
| Apr 29, 1991 | K910719 | SILICOATER MD Kulzer, Inc. | EMA |
| Mar 15, 1991 | K905131 | DURAFILL COLOR VS Kulzer, Inc. | EBF |
| Feb 26, 1991 | K905302 | DENTHESIVE Kulzer, Inc. | KLE |
| Nov 13, 1990 | K904555 | DURAFILL FLOW Kulzer, Inc. | EBF |
| Aug 13, 1990 | K903317 | DENTALON PLUS Kulzer, Inc. | EBG |
| Jul 27, 1990 | K902115 | PALAPRESS(R) VARIO RESIN Kulzer, Inc. | EBI |
| Jul 26, 1990 | K902350 | PALATRAY LC RESIN IMPRESSION TRAY MATERIAL Kulzer, Inc. | EBH |
| Jun 22, 1990 | K901789 | PALADON(R) 65 Kulzer, Inc. | EBI |
| Jun 15, 1990 | K901697 | SILISTOR CERAMIC AND RESIN REPAIR SYSTEM Kulzer, Inc. | EBF |
| Jun 15, 1990 | K901681 | FORMASIL(R)A POLYVINYL SILOXANE LINE Kulzer, Inc. | ELW |
| Dec 4, 1989 | K892453 | KULZER GLAS-IONOMER CEMENT Kulzer, Inc. | EMA |
| Jun 22, 1989 | K892455 | KULZER ADHESIVE CEMENT Kulzer, Inc. | EBF |
| Jun 16, 1989 | K892454 | KULZER INLAY SYSTEM Kulzer, Inc. | EBF |
| Jun 16, 1989 | K892452 | PALASEAL(R) Kulzer, Inc. | EBI |
| Jun 14, 1989 | K892456 | KULZER TRANSLUX EC Kulzer, Inc. | EBZ |
| Mar 18, 1988 | K875344 | HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY Kulzer, Inc. | EJJ |
| Oct 14, 1986 | K862546 | MICROFILL PONTIC Kulzer, Inc. | EBF |
| Sep 22, 1986 | K863315 | MULTIFIL(R) VS Kulzer, Inc. | EBF |
| Sep 22, 1986 | K863314 | ESTILUX(R) POSTERIOR C Kulzer, Inc. | EBF |
| Apr 22, 1985 | K850965 | KULZER DENTIN ADHESIVE Kulzer, Inc. | EBF |
| Dec 4, 1984 | K843823 | TRANSLUX CL Kulzer, Inc. | EBZ |
| Apr 13, 1984 | K840176 | ESTIC MICROFILL Kulzer, Inc. | EBF |
| Sep 12, 1983 | K831215 | DENTACOLOR LIGHT CURING CROWN & BRIDGE Kulzer, Inc. | EBF |
| Sep 12, 1983 | K831077 | DENTALON Kulzer, Inc. | EBG |
| Jan 29, 1982 | K813568 | ESTILUX POSTERIOR XR Kulzer, Inc. | EBF |
| Nov 17, 1981 | K812889 | ESTILUX POSTERIOR Kulzer, Inc. | EBF |
| Jul 28, 1981 | K811668 | KULZER TRANSLUX VISIBLE LIGHT CURING Kulzer, Inc. | EBZ |
| Jul 1, 1981 | K811669 | DURAFILL MICROFILL RESTORATIVE MATERIAL Kulzer, Inc. | EBF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||