FDA.reportPublic FDA data

HU-FRIEDY

Primary DI
10889950021030
Brand
HU-FRIEDY
Company
HU-FRIEDY MFG. CO., LLC
Model
RCP11A
Catalog number
RCP11A
Device description
511 SE Root Canal Plugger (A)
Published
2020-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
10889950021030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995002103010889950021030

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic pluggerA hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-7433info@hu-friedy.com

Regulatory Flags#

DUNS number
005085972
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
10889950157326Hu-FriedyIMNO24511C2026-05-26
10889950147020Hu-FriedyDSBH5/662026-04-17
10889950157180Hu-FriedyIM40580-C42026-04-07
10889950157197Hu-FriedyIMN9142HAS2026-04-07
10889950126339Hu-Friedy MFG Co., LLC.CLAWXS2026-04-06
10889950126346Hu-Friedy MFG Co., LLC.CLAWS2026-04-06
10889950126353Hu-Friedy MFG Co., LLC.CLAWM2026-04-06
10889950126360Hu-Friedy MFG Co., LLC.CLAWL2026-04-06
10889950126377Hu-Friedy MFG Co., LLC.CLAWXL2026-04-06
10889950126384Hu-Friedy MFG Co., LLC.CLAWXSX2026-04-06
10889950126391Hu-Friedy MFG Co., LLC.CLAWSX2026-04-06
10889950126407Hu-Friedy MFG Co., LLC.CLAWMX2026-04-06
10889950126414Hu-Friedy MFG Co., LLC.CLAWLX2026-04-06
10889950126421Hu-Friedy MFG Co., LLC.CLAWXLX2026-04-06
10889950001643Hu-Friedy Mfg. Co., LLCPSN6953LPSN6953L2015-10-16
10889950001834Hu-Friedy Mfg. Co., LLCPSN7773LPSN7773L2015-10-16
10889950002060Hu-Friedy Mfg. Co., LLCPSNR683LPSNR683L2015-10-16
10889950002077Hu-Friedy Mfg. Co., LLCPSNR698LPSNR698L2015-10-16
10889950002084Hu-Friedy Mfg. Co., LLCPSNR7772LPSNR7772L2015-10-16
10889950156008Hu-FriedyIM53FMC22026-03-05

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