FDA.reportPublic FDA data

Harmony Anterior Disposable Dual Arch Tray

Primary DI
00850211006083
Brand
Harmony Anterior Disposable Dual Arch Tray
Company
HO DENTAL COMPANY LLC
Model
Anterior
Device description
Anterior Dual Arch Impression Tray for Dental UseDisposable, Rigid, Alignment Sticks included to mark facial Mid-Line40/box
Published
2017-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EHYTray, Impression, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850211006083PrimaryGS10
00850211006489Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850211006083008502110060838502110060830850211006083
00850211006489008502110064898502110064890850211006489

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, single-useA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012676012
Device count
40
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850211006144Facial Plane RelatorFPR-1022023-05-17
00850211006229Dynamic Mixing TipsVacu-Mixer Tip2017-10-10
00850211006021Vaccu-sil VPS Heavy Body 50 Impression MaterialRegular Set2017-10-10
00850211006038Vaccu-sil VPS Heavy Body 50 Impression MaterialFast Set2017-10-10
00850211006045Vaccu-sil VPS Light Body CartridgeFast Set2017-10-10
00850211006052Vaccu-sil VPS Light Body CartridgeRegular Set2017-10-10
00850211006090Harmony Posterior Disposable Dual Arch TryPosterior2017-10-10
00850211006205Vacu-Mixer Automated VPS Mixing MachineVacu-Mixer2017-10-10
00850211006212Mojo VPS Light Body Impression SyringeEmpty2017-10-10
00850211006236Vaccu-sil VPS Heavy Body 120 Impression MaterialFast Set2017-10-10
00850211006243Vaccu-sil VPS Heavy Body 120 Impression MaterialRegular Set2017-10-10
00850211006250Vaccu-sil Bite RegistrationRegular Set2017-10-10
00850211006267Vaccu-Sil Mojo Complete Light Body SyringeRegular Set2017-10-10
00850211006274Vaccu-Sil Mojo Complete Light Body SyringeFast Set2017-10-10
00850211006311VacuCord Gingival Retraction CordSize 002017-10-11
00850211006328VacCord Gingival Retraction CordSize 02017-10-11
00850211006335VacuCord Gingival Retraction CordSize 12017-10-11
00850211006342VacuCord Gingival Retraction CordSize 22017-10-11

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