Dental Device Guide
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Registered with FDA

MHM Grupo Diamante, S.A. de C.V.

MEXICO, Mexico. Lists 16 dental device types with FDA across 1 registered establishment.

FDA owner/operator10055207Foreign exporter
Device types listed
16
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1Mexico

Devices listed with FDA

What MHM Grupo Diamante, S.A. de C.V. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Tooth Shade MaterialEBF · Class 2Dental compositesLister—2021
Porcelain PowderEIH · Class 2Dental ceramics & zirconiaLister—2021
Dental CementEMA · Class 2Dental cementsLister—2022
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsLister—2021
Root Canal Filling ResinKIF · Class 2Root canal filling materialsLister—2021
Manual ToothbrushEFW · Class 1ToothbrushesLister—2018
X-Ray Film HolderEGZ · Class 1—Lister—2026
Abrasive DiskEHJ · Class 1Polishing & prophylaxisLister—2020
Abrasive PointEHL · Class 1Polishing & prophylaxisLister—2019
Restorative and Impression Material SyringeEID · Class 1Dental hand instrumentsLister—2022
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsLister—2021
Endodontic Pulp Canal FileEKS · Class 1Endodontic filesLister—2021
Ultrasonic ScalerELC · Class 2Ultrasonic scalersLister—2026
Impression MaterialELW · Class 2Impression materialsLister—2021
Paper Saliva AbsorberKHR · Class 1—Lister—2017
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsLister—2023

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

MHM Grupo Diamante, S.A. de C.V. 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: Ivoclar Vivadent, AG (6), Sybron Dental Specialties (5), Dentsply Intl., Inc. (3), Ivoclar North America, Inc. (3), Kerr Dental Materials Center (1), Kerr Corporation (Danbury) (1), Vivadent (Usa), Inc. (1).

Decided510(k)DeviceApplicantDevice type
14 Mar 2019K183380Tetric PowerFillIvoclar Vivadent, AGEBF Resin Tooth Shade Material
7 Jun 2018K173573Tetric CADIvoclar Vivadent, AGEBF Resin Tooth Shade Material
27 Jul 2016K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental SpecialtiesKIF Root Canal Filling Resin
14 Apr 2016K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSybron Dental SpecialtiesKIF Root Canal Filling Resin
18 Oct 2012K120053IPS E.MAX PRESS - ABUTMENT SOLUTIONSIvoclar Vivadent, AGNHA Endosseous Dental Implant Abutment
29 Apr 2009K090701EMPRESS DIRECTIvoclar Vivadent, AGEBF Resin Tooth Shade Material
19 Oct 2006K062519NEXUS 3Sybron Dental SpecialtiesEMA Dental Cement
17 Jul 2006K060891VIRTUALIvoclar Vivadent, AGELW Impression Material
14 Oct 2005K051705IPS E.MAX CAD/IPS E.MAX ZIRCADIvoclar Vivadent, AGEIH Porcelain Powder
21 Jul 2004K041474MAXCEMSybron Dental SpecialtiesEMA Dental Cement
16 Jun 2004K040906CALIBRA CEMENTDentsply Intl., Inc.EMA Dental Cement
16 Jan 2002K013647REVOLUTION FORMULA 2Sybron Dental SpecialtiesEBF Resin Tooth Shade Material
27 Aug 2001K012174ERIS LAYERING MATERIALSIvoclar North America, Inc.EIH Porcelain Powder
8 Sep 1998K982616IPS EMPRESS 2Ivoclar North America, Inc.EIH Porcelain Powder
3 Oct 1997K972844TEMP BOND CLEARKerr Dental Materials CenterEMA Dental Cement
11 Apr 1997K970123DENTSPLY CAVITRON SPS SCALER SYSTEMDentsply Intl., Inc.ELC Ultrasonic Scaler
10 Jun 1994K942031CAULK TOOTH CONDITIONER GEL AND SYRINGEDentsply Intl., Inc.EBF Resin Tooth Shade Material
15 Apr 1994K940513OPTIBONDKerr Corporation (Danbury)KLE Resin Tooth Bonding Agent
25 Oct 1991K913372IPS EMPRESSIvoclar North America, Inc.EIH Porcelain Powder
24 Nov 1980K802681HELIOBONDVivadent (Usa), Inc.KLE Resin Tooth Bonding Agent

Registered establishments

EstablishmentLocationWhat it does
MHM GRUPO DIAMANTE, S.A. DE C.V.FDA reg. 3012354669MEXICO, MexicoForeign exporter

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10055207). 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.