FDA.reportPublic FDA data

EDGE ENDO

Primary DI
00810988031541
Brand
EDGE ENDO
Company
HANDPIECE PARTS & REPAIRS, INC.
Model
EE20GSIN
Catalog number
EE20GSIN
Device description
EdgeFlow E20G-S Injection needle
Published
2023-04-20
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
00810988031541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810988031541008109880315418109880315410810988031541

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation system handpiece, material extrusionA handpiece, which is part of an endodontic obturation system, intended to backfill and down pack gutta-percha (extrude) during root canal treatment or root canal obturation. Resistive heat is applied through this device around a heat chamber to heat up a cartridge of gutta-percha. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079723355
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810988030292TTBio08090012TB508090012TB52025-06-04
00810988030308TTBio08090012TB408090012TB42025-06-04
00810988030827QUALITY PLUSPB01PPB01P2023-07-17
00810988031848MEDIDENTAEJ0008-MEDI-MTEJ0008-MEDI-MT2023-07-10
10810988031302EDGE ENDOEEALULH5EEALULH52023-04-20
10810988031326EDGE ENDOEEALUFC5EEALUFC52023-04-20
00810988031312EDGE ENDOEEALUMFEEALUMF2023-04-20
00810988031336EDGE ENDOEEALUMWEEALUMW2023-04-20
00810988031350EDGE ENDOEEALUTEEALUT2023-04-20
00810988031374EDGE ENDOEEDPUEEDPU2023-04-20
00810988031404EDGE ENDOEEDPUT3504EEDPUT35042023-04-20
00810988031411EDGE ENDOEEDPUT4004EEDPUT40042023-04-20
00810988031428EDGE ENDOEEDPUT4504EEDPUT45042023-04-20
00810988031435EDGE ENDOEEDPUT5004EEDPUT50042023-04-20
00810988031442EDGE ENDOEEDPUT5506EEDPUT55062023-04-20
00810988031459EDGE ENDOEEDPUT5508EEDPUT55082023-04-20
00810988031466EDGE ENDOEEDPUT5510EEDPUT55102023-04-20
00810988031473EDGE ENDOEEDPUT5508LEEDPUT5508L2023-04-20
00810988031480EDGE ENDOEEDPUT6012EEDPUT60122023-04-20
00810988031497EDGE ENDOEEPTOEEPTO2023-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783009002Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
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
00843471100431Obtura SpartanYoung Innovations, Inc.EKR2024-01-15