FDA.reportPublic FDA data

DIA-KONDENSOR

Primary DI
08806383546133
Brand
DIA-KONDENSOR
Company
DiaDent Group International
Model
ASST
Catalog number
551-191
Device description
DIA-KONDENSOR is having both a nIckel-titanium end a stainless steel end, it can be used in any common endodontic obturation technique including warm and cold condensation.
Published
2020-05-27
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
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806383546133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806383546133088063835461338806383546133

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic filling material condenserA dental instrument that uses heat to condense an endodontic filling material in a root canal, in the axial/lateral direction. The working part is typically cylindrical or tapered, and circular in cross-section. A condenser is commonly used to function as a plugger or spreader. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687789453
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806383591690DIACEM TEMPNEDIACEM TEMPNE 3g(Type S)A2004-69122026-05-13
08806383591706DIACEM TEMPNEDIACEM TEMPNE 10g(Type S)A2004-69132026-05-13
06944835131147DIA-X FILE21mm D1/D4 Asst571-S1912026-02-20
06944835131154DIA-X FILE25mm D1/D4 Asst571-S2912026-02-20
06944835131338DIA-X FILE19mm/21mm DX/D3 Asst571-S1922026-02-20
06944835131345DIA-X FILE19mm/25mm DX/D3 Asst 571-S2912026-02-20
06944835173291DIA-X FILE19mm DX571-S1002026-02-20
06944835173307DIA-X FILE21mm D1 571-S1012026-02-20
06944835173314DIA-X FILE21mm D2 571-S1022026-02-20
06944835173321DIA-X FILE21mm D3571-S1032026-02-20
06944835173338DIA-X FILE21mm D4571-S1042026-02-20
06944835173345DIA-X FILE21mm D5 571-S1052026-02-20
06944835173369DIA-X FILE21mm D6571-S1062026-02-20
06944835173376DIA-X FILE21mm D7 571-S1072026-02-20
06944835173383DIA-X FILE25mm D1571-S2012026-02-20
06944835173390DIA-X FILE25mm D2571-S2022026-02-20
06944835173406DIA-X FILE25mm D3571-S2032026-02-20
06944835173413DIA-X FILE25mm D4571-S2042026-02-20
06944835173420DIA-X FILE25mm D5571-S2052026-02-20
06944835173444DIA-X FILE25mm D6571-S2062026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06947600328834Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L5mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328841Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328858Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328865Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328872Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328889Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328896Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328902Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328919Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328926Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328933Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328940Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328957Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328964Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328971Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328988Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328995Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329008Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329015Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329022Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329039Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329046Profile Drill,BLT,Φ3.3mm, L33mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329060Profile Drill,BLT,Φ4.1mm, L33mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329084Profile Drill,BLT,Φ4.8mm, L33mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
07899878064985NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878064992NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065005NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065012NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065029NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065036NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18