FDA.reportPublic FDA data

HU-FRIEDY

Primary DI
10889950044183
Brand
HU-FRIEDY
Company
HU-FRIEDY MFG. CO., LLC
Model
CP8020
Catalog number
CP8020
Device description
Margin Trimmer #26 with Hatchet Blade
Published
2020-11-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJZKNIFE, MARGIN FINISHING, OPERATIVE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950044183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995004418310889950044183

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
08800075604484OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-26
08800075604460OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
08800075604477OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
08800075604491OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
10889950110512Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-07-19
10889950110529Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-07-19
10889950121204Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-06-27
10889950043360Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950043377Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950080662Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950080679Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
D943G18010GargPower Dental U.S.A. Inc.EJZ2023-02-28
D943G18120GargPower Dental U.S.A. Inc.EJZ2023-02-28
10889950139353Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139360Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139414Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139421Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139438Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139513Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950044251HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2022-01-20
10889950133153Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2021-10-08
D9431816D0Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431812M00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431816D00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431812L00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D943N1812L00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D943N1812M00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D943N1816D00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D94318020Power Dental USAPower Dental U.S.A. Inc.EJZ2021-06-20
D94318130Power Dental USAPower Dental U.S.A. Inc.EJZ2021-06-20