FDA.reportPublic FDA data

DIA-PEN

Primary DI
08806383538947
Brand
DIA-PEN
Company
DiaDent Group International
Model
DIA-PEN,REGULAR KIT
Catalog number
4002-1001
Device description
Dia-Pen supports warm vertical compaction and has proven to be effectice as an integral part of downpack obturator system.
Published
2020-05-26
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
EKRPlugger, Root Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806383538947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806383538947088063835389478806383538947

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation systemAn assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

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
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
08806383525039DIA-X FILE19mm DX571-S1002026-06-15
08806383525046DIA-X FILE21mm D1571-S1012026-02-20
08806383525077DIA-X FILE21mm D4571-S1042026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535018981Brasseler USAPeter Brasseler Holdings, LLCEKR2026-06-26
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00348783009019Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009026Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009033Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009057Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783008975Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008982Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008999Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009125Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009132Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009149Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008913Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008920Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008937Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008944Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008951Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009088Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009095Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009101Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009118Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
E89616970207E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E89616970307E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E89616970TI07E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E896169701TI07E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-07-16
E8961697020TI0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-06-24
00813677024480PDT, Inc.PDT, INC.EKR2024-06-27
00813677024985PDT, Inc.PDT, INC.EKR2024-06-27
00843471100288Obtura SpartanYoung Innovations, Inc.EKR2024-01-15
00843471100301Obtura SpartanYoung Innovations, Inc.EKR2024-01-15