FDA.report

Midway Select

Primary DI
10843717103100
Brand
Midway Select
Company
MIDWAY DENTAL SUPPLY, LLC
Model
002-0311
Device description
Midway Select Disposable Diamonds 856-016C, Pkg/25
Published
2019-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10843717103100PrimaryGS10
00843717103103Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084371710310010843717103100
00843717103103008437171031038437171031030843717103103

GMDN Terms

TermDefinition
Diamond dental bur, single-useA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
102354446
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10843717100536Midway Select002-00552019-01-14
10843717100512Midway Select002-00512018-11-19
10843717103414Midway Select002-03402019-07-19
10843717103384Midway Select002-03372019-07-19
10843717103407Midway Select002-03392019-07-19
10843717100079Midway Select002-0029002-00292018-08-23
10843717101120Midway Select002-00522018-11-19
10843717100505Midway Select002-00502018-11-19
10843717103391Midway Select002-03382019-07-19
00843717100492Midway Select002-00702022-08-31
00843717102632Midway Select002-02652022-08-26
00843717102649Midway Select002-02662022-08-26
00843717102656Midway Select002-02672022-08-26
00843717100485Midway Select002-01912022-08-26
00843717101147Midway Select002-01922022-08-26
00843717101154Midway Select002-01932022-08-26
00843717102144Midway Select002-02032022-08-26
00843717102151Midway Select002-02042022-08-26
00843717102168Midway Select002-02102022-08-26
00843717102175Midway Select002-02112022-08-26

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B868CV1600050Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
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D690W801014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801018M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801021C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801023M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L016C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L018M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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D690W805014C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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D690W811031M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W830008M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W830010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16