Data / Medical devices / Mexico / MHM Grupo Diamante, S.A. De C.V.
MHM Grupo Diamante, S.A. De C.V.: FDA-registered device maker in Mexico, Mexico, 26 510(k) clearances
MHM Grupo Diamante, S.A. De C.V. is registered with the FDA (registration 3012354669) in Mexico, Mexico. It lists 24 device types. The FDA files 26 510(k) clearances under its listings, the newest dated March 14, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012354669
- Address
- Hacienda El Ciervo 33-304, Mexico, Mexico, 52763
- Owner or operator
- MHM GRUPO DIAMANTE, S.A. DE C.V. (10055207)
- Roles
- Exporter to the US
- First device listed
- June 20, 2017
- Registered through
- 2026
- Brand names listed
- Perry 42
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 |
|---|---|---|---|---|---|---|
| March 14, 2019 | K183380 | Tetric PowerFill | EBF | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| June 7, 2018 | K173573 | Tetric CAD | EBF | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| July 27, 2016 | K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | KIF | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| April 14, 2016 | K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | KIF | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| October 18, 2012 | K120053 | IPS E.MAX PRESS - ABUTMENT SOLUTIONS | NHA | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| July 7, 2011 | K103714 | ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| April 29, 2009 | K090701 | EMPRESS DIRECT | EBF | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| October 16, 2008 | K082258 | CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR | FXX | Substantially Equivalent | Crosstex International | accessdata.fda.gov |
| October 19, 2006 | K062519 | NEXUS 3 | EMA | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| July 17, 2006 | K060891 | VIRTUAL | ELW | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| October 14, 2005 | K051705 | IPS E.MAX CAD/IPS E.MAX ZIRCAD | EIH | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| July 21, 2004 | K041474 | MAXCEM | EMA | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| June 16, 2004 | K040906 | CALIBRA CEMENT | EMA | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| January 16, 2002 | K013647 | REVOLUTION FORMULA 2 | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| August 27, 2001 | K012174 | ERIS LAYERING MATERIALS | EIH | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| October 28, 1998 | K982541 | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 | FMI | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| September 8, 1998 | K982616 | IPS EMPRESS 2 | EIH | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| October 3, 1997 | K972844 | TEMP BOND CLEAR | EMA | Substantially Equivalent | Kerr Dental Materials Center | accessdata.fda.gov |
| April 11, 1997 | K970123 | DENTSPLY CAVITRON SPS SCALER SYSTEM | ELC | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| June 10, 1994 | K942031 | CAULK TOOTH CONDITIONER GEL AND SYRINGE | EBF | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| April 15, 1994 | K940513 | OPTIBOND | KLE | Substantially Equivalent | Kerr Corporation (Danbury) | accessdata.fda.gov |
| October 25, 1991 | K913372 | IPS EMPRESS | EIH | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| July 23, 1990 | K901845 | TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX | KGX | Substantially Equivalent for Some Indications | 3M Company | accessdata.fda.gov |
| February 9, 1983 | K813265 | 3M STERI-STRIP ANTIMICROBIAL SKIN CLOS | KGX | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| November 24, 1980 | K802681 | HELIOBOND | KLE | Substantially Equivalent | Vivadent (Usa), Inc. | accessdata.fda.gov |
| June 20, 1980 | K801343 | B-D FILTER NEEDLE | FPB | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Compare with other makers
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- All makers of Tape And Bandage, Adhesive
Updated March 14, 2019. 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.