FDA.reportPublic FDA data

Dental Mates

Primary DI
00860009046450
Brand
Dental Mates
Company
M.Y.T. USA Corp.
Model
ASTM LEVEL 3 MASK
Published
2022-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2025980003 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 33A Medical Products Co., Ltd.2021-05-06FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009046450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009046450008600090464508600090464500860009046450

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, non-antimicrobial, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118764392
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00080169153595BORDOVAVINYL EXAM GLOVES SIZE LARGE2022-11-30
00840169153793Dental Mates"Sterilization Pouches 7 1/2 X 14"""2023-02-25
00840169153588BORDOVAVINYL EXAM GLOVES SIZE MEDIUM2022-11-30
00840169153601PLATINUMVINYL EXAM GLOVES SIZE MEDIUM2022-11-30
00840169153618PLATINUMVINYL EXAM GLOVES SIZE LARGE2022-11-30
00860009046467Dental MatesSterilization Pouches 2 1/4 x 52022-11-17
00860009046474Dental MatesSterilization Pouches 3 1/2 x 6 1/22022-11-17
00860009046481Dental MatesSterilization Pouches 3 1/2 x 102022-11-17
00840169153540Dental MatesLATEX EXAM GLOVES SIZE SMALL2022-11-16
00840169153557Dental MatesLATEX EXAM GLOVES SIZE MEDIUM2022-11-16
00840169153564Dental MatesLATEX EXAM GLOVES SIZE LARGE2022-11-16
00840169153571Dental MatesLATEX EXAM GLOVES SIZE XL2022-11-16
00840169153533Dental MatesLATEX EXAM GLOVES XS2022-11-14
00860009046405Dental MatesSize XS2022-08-17
00860009046412Dental MatesSize Small2022-08-17
00860009046429Dental MatesSize Medium2022-08-17
00860009046436Dental MatesSize Large2022-08-17
00860009046443Dental MatesSize XL2022-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16980077680149AOKAOK TOOLING LIMITEDFXX2026-06-04
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16980077680071AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680088AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
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00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011613Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604553022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21