FDA.reportPublic FDA data

DISPOSABLE TIPS

Primary DI
08806383565615
Brand
DISPOSABLE TIPS
Company
DiaDent Group International
Model
CURVED, Blue
Catalog number
A2001-6103
Device description
Disposable Tips for DiaEtch
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JEWTip, Rubber, Oral Hygiene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEWTip, Rubber, Oral HygieneDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806383565615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806383565615088063835656158806383565615

GMDN Terms#

Term, Definition table
TermDefinition
Root canal irrigation blunt needleA slender, hollow, tubular, metal instrument with a blunt tip designed specifically for irrigation of the root canal of a tooth during an endodontic procedure. Sometimes referred to as a root canal irrigation cannula, it is typically attached to a dental syringe (not included) filled with a root canal cleaning solution. It might be bent or straight and might have either a side vented tip or a blunt open-ended tip. This is a single-use 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
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
G149TBSB1280TBS BASICSACME ENTERPRISE.JEW2026-05-20
003598830024662.5 Mixing Tips with 20ga Integrated Needle 25-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
003598830024732.5 Mixing Tips with 17ga Integrated Needle 25-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
003598830024803.2 Mixing Tips with Integrated Needle 25-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
003598830024974.2 Mixing Tips with Integrated Needle 25-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003395Universal Needle Tips 18G (Pink) 100-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003401Universal Needle Tips 20G (Black) 100-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003418Universal Needle Tips 22G (Grey) 100-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003425Universal Needle Tips 25G (Blue) 100-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003432Flocked Needle Tips (Black)DEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883004118Clinician's Choice® Needle Tubes & PlugsDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883005221Max Etch 35% Phosphoric Acid Etch 5mLDEN-MAT HOLDINGS, LLCJEW2025-03-12
05061035460486Love NoobsROBUST VENTURES LTDJEW2024-11-29
08806383565608DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383565660DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383565677DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383586696DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383561921DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-26
10818207024005Vista Pocket ProbeVista DentalJEW2022-09-01
075401720190022.5 Mixing Tips with 20ga Integrated Needle (Brown)CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2022-03-24
04064896000533Monolith Etching-Gel-TipsPRISMAN INC.JEW2021-11-02
07540172002240Clinician's Choice® High Viscosity Tubes & PlugsCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-22
07540172002257Clinician's Choice® Low Viscosity Tubes & PlugsCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-22
07540172002264Clinician's Choice® Needle Tubes & PlugsCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-22
075401720006042.5 Mixing Tips with Integrated NeedleCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
075401720006113.2 Mixing Tips with Integrated NeedleCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
075401720006284.2 Mixing Tips with Integrated NeedleCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
07540172001601Universal Needle Tips (Pink)CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
07540172001618Universal Needle Tips (Black)CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21