FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040047637
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1011984
Catalog number
1011984
Device description
Plugger Root Canal 11P
Published
2019-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00304040047637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040047637003040400476373040400476370304040047637

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
012430880
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535019247Brasseler USAPeter Brasseler Holdings, LLCEKR2026-03-24
00348783008968Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-03-17
00348783009040Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-03-17
00348783009064Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-03-17
00348783009071Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-03-17
00840018667525Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKR2026-02-10
06941877827816ZarcChangzhou Sifary Medical Technology Co., Ltd.EKR2026-01-05
06941877827823ZarcChangzhou Sifary Medical Technology Co., Ltd.EKR2026-01-05
E896169520SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-05-19
E896169710007E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-04-07
E89616971TI06E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-04-07
08806383586313DUO-GUNDiaDent Group InternationalEKR2025-03-12
08806383586320DUO-PENDiaDent Group InternationalEKR2025-03-12
06944843619071EDEGENDOGuilin Woodpecker Medical Instrument Co., Ltd.EKR2025-03-11
06944843619088EDEGENDOGuilin Woodpecker Medical Instrument Co., Ltd.EKR2025-03-11
06970873260389Integrated Endo SystemDENJOY DENTAL CO.,LTDEKR2025-02-28
04260482991166EndoPilot D-Pack² handpieceSchlumbohm GmbH & Co. KGEKR2025-01-28
04260482991173EndoPilot² expansion DownPack²Schlumbohm GmbH & Co. KGEKR2025-01-28
08809455602164elements IC META SYSTEMS CO., LTD.EKR2024-12-30
08809455602171elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602188elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602195elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602386elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602393elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602409elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
00889813066836Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKR2024-12-12
08800019101581NeedleB& L Biotech, inc.EKR2024-12-03
08800019102168NeedleB& L Biotech, inc.EKR2024-12-03
08800019102175NeedleB& L Biotech, inc.EKR2024-12-03
08800019102182NeedleB& L Biotech, inc.EKR2024-12-03