FDA.reportPublic FDA data

HU-FRIEDY

Primary DI
10889950004293
Brand
HU-FRIEDY
Company
HU-FRIEDY MFG. CO., LLC
Model
AF1/4
Catalog number
AF1/4
Device description
#1/4 DE Amalgam 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
10889950004293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995000429310889950004293

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. 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
10889950004316HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12
10889950041427HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12
10889950123673HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12
10889950004309HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12