FDA.reportPublic FDA data

ALUMINUM BOX_Medium Square

Primary DI
08806383523189
Brand
ALUMINUM BOX_Medium Square
Company
DiaDent Group International
Model
RED
Catalog number
804-003
Device description
Clean grip for hand & rotary files as well as cups for Gutta Percha & Paper Points
Published
2020-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806383523189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806383523189088063835231898806383523189

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic instrument chairside holder setA collection of devices intended to be used chairside during a endodontic procedure to facilitate the access, handling, temporary storage and convenient selection of endodontic instruments (e.g., files/rasps). The set may be positioned on a surface or worn by the operator (e.g., ring design) and typically includes a plastic housing/rack, disposable spongy foam inserts for holding delicate and sharp rotary endpieces, holders for fluid containers, colour-coded identification labels/tags, and a ruler to help select an appropriate size instrument. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687789453
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806383591676DIAFIL Bulk FLOWRefill PackageA2004-69102026-07-24
08806383591720DIAFIL Bulk FLOWSample 0.5gA2004-69152026-07-24
08806383591911DIAFIL Bulk FLOWEconomic PackageA2004-69092026-07-24
08806383591737DIA-CEMDIA-CEM TR 3gA2004-69002026-07-20
08806383591751DIA-CEMDIA-CEM A2 3gA2004-69022026-07-20
08806383591775DIA-CEMDIA-CEM A3O 3gA2004-69042026-07-20
08806383591959DIA-CEMDIA-CEM TR 9gA2004-21222026-07-20
08806383591966DIA-CEMDIA-CEM A2 9gA2004-21232026-07-20
08806383591973DIA-CEMDIA-CEM A3O 9gA2004-21242026-07-20
06944835173291DIA-X FILE19mm DX571-S1002026-02-20
06944835173314DIA-X FILE21mm D2571-S1022026-02-20
06944835173321DIA-X FILE21mm D3571-S1032026-02-20
06944835173369DIA-X FILE21mm D6571-S1062026-02-20
06944835173376DIA-X FILE21mm D7571-S1072026-02-20
06944835173444DIA-X FILE25mm D6571-S2062026-02-20
06944835173451DIA-X FILE25mm D7571-S2072026-02-20
08806383585873DiaCemTempNEDiaCemTempNE 10g (A type)A2003-31012022-08-16
08806383585897DiaCemTempNEDiaCemTempNE 10g (B type)A2003-31022022-08-16
08806383585910DiaCemTempNEDiaCemTempNE 10g (C type)A2003-31032022-08-16
08806383585934DiaCemTempNEDiaCemTempNE 3gA2003-61022022-08-16

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