FDA.reportPublic FDA data

Artman Instruments

Primary DI
D1272424381
Brand
Artman Instruments
Company
Wise Linkers, LLC
Model
242438
Catalog number
1
Device description
Bone File
Published
2023-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMIFile, Bone, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMIFile, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D1272424381PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is 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 not dedicated for use at a specific anatomy (e.g., sinus, ear) and 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

Regulatory Flags#

DUNS number
081170668
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
D1272421121Artman Instruments 24211212023-03-29
D1272421181Artman Instruments 24211812023-03-29
D1272421221Artman Instruments 24212212023-03-29
D1272421341Artman Instruments 24213412023-03-29
D127242135A1Artman Instruments 242135A12023-03-29
D1272421411Artman Instruments 24214112023-03-29
D1272421431Artman Instruments 24214312023-03-29
D1272421531Artman Instruments 24215312023-03-29
D1272421781Artman Instruments 24217812023-03-29
D1272422161Artman Instruments 24221612023-03-29
D1272422191Artman Instruments 24221912023-03-29
D1272422391Artman Instruments 24223912023-03-29
D1272422541Artman Instruments D12724225412023-03-29
D1272422651Artman Instruments 24226512023-03-29
D1272422691Artman Instruments 24226912023-03-29
D1272422761Artman Instruments 2422762023-03-29
D1272423041Artman Instruments 24230412023-03-29
D1272423051Artman Instruments 24230512023-03-29
D1272423091Artman Instruments 2423092023-03-29
D1272423141Artman Instruments 24231412023-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783010053Premier FilePREMIER DENTAL PRODUCTS COMPANYEMI2026-04-27
00840018672642Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-11
00840018663589Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-04
00840018665514Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-04
00840018662476Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00840018662858Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00840018663220Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00194613115968MSI Precision Specialty InstrumentsMed Saver, Inc.EMI2025-08-01
00190776405229MillenniumAvalign Technologies, Inc.EMI2025-07-14
00889813066874Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEMI2025-02-12
00889813066881Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEMI2025-02-12
00840306823619Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EMI2025-01-17
00840306823626Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EMI2025-01-17
00813677025135PDT, Inc.PDT, INC.EMI2024-08-12
06974456210761CICADAFoshan Cicada Dental Instrument Co., Ltd.EMI2024-08-10
86974456210767CICADAFoshan Cicada Dental Instrument Co., Ltd.EMI2024-08-10
00813677024558PDT, Inc.PDT, INC.EMI2024-07-03
00813677024497PDT, Inc.PDT, INC.EMI2024-06-27
00190776388911AvalignAvalign Technologies, Inc.EMI2024-05-15
00842517105638Karl SchumacherKarl Schumacher Dental, LLCEMI2024-03-18
00842517105645Karl SchumacherKarl Schumacher Dental, LLCEMI2024-03-18
00888515225336BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
00888515225374BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
00888515225497BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
08800075612892OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-27
08800075612908OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-27
08800075612878OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-19
D955BFS3201Paul BandittTerlain Enterprises, Inc.EMI2023-12-11
D955BFX1101Paul BandittTerlain Enterprises, Inc.EMI2023-12-11
D955BFX12C1Paul BandittTerlain Enterprises, Inc.EMI2023-12-11