FDA.reportPublic FDA data

EDGE ENDO

Primary DI
00810988031374
Brand
EDGE ENDO
Company
HANDPIECE PARTS & REPAIRS, INC.
Model
EEDPU
Catalog number
EEDPU
Device description
EdgePack Downpack Unit
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
00810988031374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810988031374008109880313748109880313740810988031374

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation system handpiece, heat conductingA handpiece, which is part of an endodontic obturation system, intended to control through its hand-switch an electrical current from the generator to the tip of an attached dental instrument where it is converted to resistive heat used to test tooth response to thermal stimulus during treatment involving root canal obturation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079723355
Device count
1
Premarket exempt
true
Serial number
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
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
00810988031541EDGE ENDOEE20GSINEE20GSIN2023-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979865810038JAS MotorDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810137JAS Heat Plugger TipDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810168JAS Pack Gutta-Percha CutterDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDEKR2026-09-24
G8791062850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKR2026-08-08
G8791062880DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKR2026-08-08
08404535018981Brasseler USAPeter Brasseler Holdings, LLCEKR2026-06-26
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