Data / Medical devices / United States / Hexa Dental
Hexa Dental: FDA-registered device maker in Commerce, CA, United States, 20 510(k) clearances
Hexa Dental is registered with the FDA (registration 3014615644) in Commerce, CA, United States. It lists 22 device types. The FDA files 20 510(k) clearances under its listings, the newest dated October 14, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014615644
- Address
- 5211 E. Washington Blv. #2-201, Commerce, CA, United States, 90040
- Owner or operator
- HEXA Dental (10059459)
- Roles
- Contract manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- January 28, 2019
- Registered through
- 2027
- Brand names listed
- Dental Cement, HEXA, Hexa, Hexa Bonding, Hexa Composite, Hexa Freeze
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 14, 2021 | K210231 | Vittra APS Unique | EBF | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| December 22, 2020 | K201707 | Opallis, Opallis Flow | EBF | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| December 13, 2019 | K183424 | Ambar, Ambar APS, Ambar Universal APS | KLE | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| November 2, 2019 | K183465 | Allcem, Allcem Core | EMA | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| September 4, 2019 | K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | EBF | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| January 13, 2014 | K133021 | MIXING SYRINGE SYSTEM | FMF | Substantially Equivalent | Zimmer Knee Creations, Inc. | accessdata.fda.gov |
| August 23, 2012 | K121824 | ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 | ELW | Substantially Equivalent | Lascod Spa | accessdata.fda.gov |
| December 8, 2010 | K102739 | HYDROCOLOR 5 | ELW | Substantially Equivalent | Cascades Device Consulting Associates | accessdata.fda.gov |
| November 10, 2010 | K103164 | VONFLEX HEAVY, VINFLEX LIGHT | ELW | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| July 23, 2010 | K100247 | DETAX IMPLANTLINK SEMI | EMA | Substantially Equivalent | Detax GmbH & Co. KG | accessdata.fda.gov |
| February 17, 2010 | K100290 | ESTEMP NE | EMA | Substantially Equivalent | Spident Co., Ltd. | accessdata.fda.gov |
| September 8, 2008 | K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT | ELW | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| June 9, 2008 | K080684 | WG-SURGICAL SUTURES WITH NEEDLE | GAP | Substantially Equivalent | Foosin Medical Supplies, Inc. | accessdata.fda.gov |
| April 30, 2008 | K073614 | WG-SURGICAL SUTURES WITH NEEDLE | NEW | Substantially Equivalent | Foosin Medical Supplies, Inc. | accessdata.fda.gov |
| June 10, 2005 | K033720 | ARI COLD SPRAY | MLY | Substantially Equivalent | Ari | accessdata.fda.gov |
| February 16, 2000 | K994012 | TEMPOFIT, MODEL 02693 | EBG | Substantially Equivalent | Detax GmbH & Co. KG | accessdata.fda.gov |
| April 2, 1999 | K990314 | MULTI-CURE COMPOSITE CEMENT | EBF | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
| September 14, 1998 | K982191 | CHEMICAL CURE COMPOSITE WITH ENAMEL BOND | EBF | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
| November 25, 1997 | K973541 | MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED | EBC | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
| April 11, 1986 | K860633 | FLUOROSEAL, DENTIN SEALER AND CAVITY LINER | LBH | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Agent, Tooth Bonding, Resin
- All makers of Diammine Silver Fluoride Dental Hypersensitivity Varnish
- All makers of Material, Impression
- All makers of Varnish, Cavity
- All makers of Material, Tooth Shade, Resin
Updated October 14, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.