Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012354669

FEI Number

3012354669

Entity Name

MHM GRUPO DIAMANTE, S.A. DE C.V.

City/State/Country

MEXICO, MX

Establishment Address

HACIENDA EL CIERVO 33-304, MEXICO 52763, MX

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

MHM GRUPO DIAMANTE, S.A. DE C.V. (Owner Number: 10055207)

Owner / Operator Contact Address

HACIENDA EL CIERVO 33-304, MEXICO, MX-MEX 52763, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K901845

PMA Number

N/A

All Registered Proprietary Names

Perry 42

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2023-02-28
EMA	Cement, Dental	Dental	Class 2	872.3275	2026-03-30
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2023-06-21
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2021-12-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-02-18
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-04-11
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2022-04-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2022-02-18
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2017-06-20
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-11-03
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2018-04-20
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2023-06-29
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-11-17
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2021-11-03
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2022-02-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-06-28
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2026-03-30
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-11-03
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-11-03
ELW	Material, Impression	Dental	Class 2	872.3660	2021-11-03
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2021-12-20
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2026-01-19
EMA	Cement, Dental	Dental	Class 2	872.3275	2022-02-18
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2022-02-18
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2021-12-20
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-10-31

Official Correspondent

MARGARITA HABER

US Agent Details

Michael Antar Email: maamds@gmail.com Phone: (848) 8883373

Related Public Records

Same Entity

MHM GRUPO DIAMANTE, S.A. DE C.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012354669. Last updated year: 2026. Please use registration number 3012354669 when referencing this establishment in official correspondence.