FDA.reportPublic FDA data

HU-FRIEDY

Primary DI
10889950047207
Brand
HU-FRIEDY
Company
HU-FRIEDY MFG. CO., LLC
Model
EL1409
Catalog number
EL1409
Device description
KJWCR CROWN REM. W/CROSS BAR
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
EISREMOVER, CROWN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EISRemover, CrownDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950047207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995004720710889950047207

GMDN Terms#

Term, Definition table
TermDefinition
Dental elevator, tooth/rootA hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. 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
G149TBSB4270TBS BASICSACME ENTERPRISE.EIS2026-05-20
00348783010114Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010121Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010138Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010145Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010152Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010169Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010176Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
G14934001F08TBS DentalACME ENTERPRISE.EIS2026-03-02
04963931210794NAYDM CORPORATIONEIS2025-12-05
04963931210800NAYDM CORPORATIONEIS2025-12-05
00841336106086Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108646Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108660Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
08800075627346OSUNG MNDOSUNG MND Co., Ltd.EIS2025-11-03
08800075627353OSUNG MNDOSUNG MND Co., Ltd.EIS2025-11-03
00841336100916Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125551Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125568Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125575Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125582Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125599Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
06974456210815CICADAFoshan Cicada Dental Instrument Co., Ltd.EIS2024-08-10
00813677025098PDT, Inc.PDT, INC.EIS2024-07-03
00813677023292PDT, Inc.PDT, INC.EIS2024-07-02
00813677024565PDT, Inc.PDT, INC.EIS2024-07-02
00813677023285PDT, Inc.PDT, INC.EIS2024-07-01
00813677023544PDT, Inc.PDT, INC.EIS2024-07-01
00813677023551PDT, Inc.PDT, INC.EIS2024-07-01
D105SKU1311760SurgiMac Surgimac LLCEIS2024-05-10