FDA.reportPublic FDA data

HU-FRIEDY

Primary DI
10889950123673
Brand
HU-FRIEDY
Company
HU-FRIEDY MFG. CO., LLC
Model
3N0181
Catalog number
3N0181
Device description
DEXL PENN 32 FILE
Published
2020-11-12
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
EKAFILE, MARGIN FINISHING, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKAFile, Margin Finishing, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950123673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995012367310889950123673

GMDN Terms#

Term, Definition table
TermDefinition
Margin finishing dental file/rasp, reusableA hand-held manual dental instrument that has various forms of fine ridged cutting surfaces at its working end(s) designed to smooth and shape a tooth, an approximate bone (e.g., alveolar) and/or a dental restoration (e.g., filling). It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
08800075612915OSUNG MNDOSUNG MND Co., Ltd.EKA2024-02-27
08800075612953OSUNG MNDOSUNG MND Co., Ltd.EKA2024-02-27
08800075612960OSUNG MNDOSUNG MND Co., Ltd.EKA2024-02-27
08800075623294OSUNG MNDOSUNG MND Co., Ltd.EKA2024-02-27
08800075612922OSUNG MNDOSUNG MND Co., Ltd.EKA2024-02-19
00840105207481ZOLL-DENTALZoll-DentalEKA2021-03-10
00840105207498ZOLL-DENTALZoll-DentalEKA2021-03-10
00840105207504ZOLL-DENTALZoll-DentalEKA2021-03-10
00840105207511ZOLL-DENTALZoll-DentalEKA2021-03-10
00840105207528ZOLL-DENTALZoll-DentalEKA2021-03-10
00840105207535ZOLL-DENTALZoll-DentalEKA2021-03-10
00840105207542ZOLL-DENTALZoll-DentalEKA2021-03-10
10889950004293HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12
10889950004316HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12
10889950041427HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12
10889950004309HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12