FDA.reportPublic FDA data

Midway Select

Primary DI
10843717106927
Brand
Midway Select
Company
MIDWAY DENTAL SUPPLY, LLC
Model
002-0520
Device description
Paper Points, Taper .04, Size #80, 100pcs/box
Published
2021-04-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EKMGutta-Percha

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843717106927PrimaryGS10
00843717106920Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084371710692710843717106927
00843717106920008437171069208437171069200843717106920

GMDN Terms#

Term, Definition table
TermDefinition
Dental root surface conditionerA dental material, typically of neutral pH, used for topical application on exposed/scaled root surfaces for the removal of the smear layer (adherent debris produced when cutting the enamel or dentin in cavity or endodontic preparation, Circa 1 micron thick) during dental/periodontal surgery. The material is removed (washed off) after the recommended period to expose the collagenous matrix of dentine surfaces. It is typically presented in the form of a gel and consists of, e.g., edetate disodium (EDTA) and carboxymethylcellulose (CMC) with a neutral pH. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
102354446
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10843717100574Midway Select002-00592019-01-14
10843717100598Midway Select002-00612019-01-14
10843717100734Midway Select002-00672019-01-14
10843717100758Midway Select002-00652019-01-14
10843717102547Midway Select002-02572019-07-19
10843717102721Midway Select002-02582019-07-19
10843717106699Midway Select002-04952021-04-05
10843717106705Midway Select002-04962021-04-05
10843717106712Midway Select002-04972021-04-05
10843717106729Midway Select002-04982021-04-05
10843717106736Midway Select002-04992021-04-05
10843717106743Midway Select002-05002021-04-05
10843717106750Midway Select002-05012021-04-05
10843717106767Midway Select002-05022021-04-05
10843717106774Midway Select002-05032021-04-05
10843717106781Midway Select002-05042021-04-05
10843717106798Midway Select002-05052021-04-05
10843717106804Midway Select002-05062021-04-05
10843717106811Midway Select002-05092021-04-05
10843717106828Midway Select002-05102021-04-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809263708737MX 04-20Meta Biomed Co., Ltd.EKM2026-10-28
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08809263708850MX 06-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708867MX 06-25Meta Biomed Co., Ltd.EKM2026-10-28
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08809263708881MX 06-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708898MX 06-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708904MG 02-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708911MG 02-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708928MG 02-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708935MG 02-30Meta Biomed Co., Ltd.EKM2026-10-28
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08809263708959MG 02-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263709567MG 04-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263709574MG 04-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263709581MG 04-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263709598MG 04-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263709604MG 04-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263709611MG 04-40Meta Biomed Co., Ltd.EKM2026-10-28