Manufacturer registered with FDA
HEXA Dental
Commerce, CA, United States. Lists 11 dental device types with FDA across 1 registered establishment.
- Device types listed
- 11
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What HEXA Dental currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Hexa BondingHexa Composite | 2019 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2020 |
| Dental CementEMA · Class 2 | Dental cements | Lister | Dental Cement | 2020 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | — | 2019 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2020 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | — | 2021 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | HEXA | 2024 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | HEXA | 2024 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | — | 2023 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | — | 2023 |
| Diammine Silver Fluoride Dental Hypersensitivity VarnishPHR · Class 2 | — | Maker | — | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
HEXA Dental lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dentscare Ltda (5), Medental Intl. (3), Lascod Spa (1), Cascades Device Consulting Associates (1), Vericom Co., Ltd. (1), Detax GmbH & Co. KG (1), Spident Co., Ltd. (1), Kettenbach GmbH & Co. KG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Oct 2021 | K210231 | Vittra APS Unique | Dentscare Ltda | EBF Resin Tooth Shade Material |
| 22 Dec 2020 | K201707 | Opallis, Opallis Flow | Dentscare Ltda | EBF Resin Tooth Shade Material |
| 13 Dec 2019 | K183424 | Ambar, Ambar APS, Ambar Universal APS | Dentscare Ltda | KLE Resin Tooth Bonding Agent |
| 2 Nov 2019 | K183465 | Allcem, Allcem Core | Dentscare Ltda | EMA Dental Cement |
| 4 Sep 2019 | K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | Dentscare Ltda | EBF Resin Tooth Shade Material |
| 23 Aug 2012 | K121824 | ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 | Lascod Spa | ELW Impression Material |
| 8 Dec 2010 | K102739 | HYDROCOLOR 5 | Cascades Device Consulting Associates | ELW Impression Material |
| 10 Nov 2010 | K103164 | VONFLEX HEAVY, VINFLEX LIGHT | Vericom Co., Ltd. | ELW Impression Material |
| 23 Jul 2010 | K100247 | DETAX IMPLANTLINK SEMI | Detax GmbH & Co. KG | EMA Dental Cement |
| 17 Feb 2010 | K100290 | ESTEMP NE | Spident Co., Ltd. | EMA Dental Cement |
| 8 Sep 2008 | K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT | Kettenbach GmbH & Co. KG | ELW Impression Material |
| 16 Feb 2000 | K994012 | TEMPOFIT, MODEL 02693 | Detax GmbH & Co. KG | EBG Resin Temporary Crown and Bridge |
| 2 Apr 1999 | K990314 | MULTI-CURE COMPOSITE CEMENT | Medental Intl. | EBF Resin Tooth Shade Material |
| 14 Sep 1998 | K982191 | CHEMICAL CURE COMPOSITE WITH ENAMEL BOND | Medental Intl. | EBF Resin Tooth Shade Material |
| 25 Nov 1997 | K973541 | MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED | Medental Intl. | EBC Pit and Fissure Sealant and Conditioner |
| 11 Apr 1986 | K860633 | FLUOROSEAL, DENTIN SEALER AND CAVITY LINER | Scientific Pharmaceuticals | LBH Cavity Varnish |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HEXA DENTALFDA reg. 3014615644 | Commerce, CA, United States | Contract manufacturer, Manufacturer for export, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059459). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.