FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919761143
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5025499U0
Device description
BFM3X MILLER BONE FILE 1P
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EMRFILE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMRFile, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919761143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919761143008879197611438879197611430887919761143

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
082080136
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919838074Brasseler USA5027336U05027336U02023-01-25
00887919711650Brasseler USA5024422U05024422U02026-06-19
00887919711681Brasseler USA5024423U05024423U02026-06-19
00887919683902Brasseler USA5023604U05023604U02026-07-13
08404535030761Brasseler USA5032375U05032375U02026-07-13
08404535030792Brasseler USA5032376U05032376U02026-07-13
08404535030822Brasseler USA5032378U05032378U02026-07-13
08404535018981Brasseler USA5031820U05031820U02026-06-26
08404535019018Brasseler USA5031821U05031821U02026-06-26
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27
08404535029611Brasseler USA Sterile Diamond004820SP004820SP2026-05-27
08404535029642Brasseler USA Sterile Diamond004868SP004868SP2026-05-27
08404535029673Brasseler USA Sterile Diamond004959SP004959SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D9284004001CH0PERIO FILE SUGARMAN 1S D/E CH HANDLE SPECIAL DR SINW.H. Holden, Inc.EMR2026-03-18
D9284004002CH0PERIO FILE SUGARMAN 2S D/E CH HANDLE SPECIAL DR SINW.H. Holden, Inc.EMR2026-03-18
D928400400CH0PERIO FILE SUGARMAN 1S/2S D/E CH HANDLEW.H. Holden, Inc.EMR2026-03-18
D928400400HD0PERIO FILE SUGARMAN 1S/2S D/E HD HANDLEW.H. Holden, Inc.EMR2026-03-18
D928400400HF0PERIO FILE SUGARMAN 1S/2S D/E HF HANDLEW.H. Holden, Inc.EMR2026-03-18
D928400435RD0PERIO FILE SCHLUGER 9/10 D/E ROUND HANDLEW.H. Holden, Inc.EMR2026-03-18
00840018665767Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMR2026-02-09
00840018665774Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMR2026-02-09
00841336110854Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMR2024-12-11
00813677024756PDT, Inc.PDT, INC.EMR2024-05-22
00842517113688Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517118973Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119048Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119055Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119109Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517106093Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00842517106109Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00842517106130Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00841336101203Salvin Freer Periosteal ElevatorsSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336101227Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102286Salvin Goldman-Fox Periosteal Elevator - 17cmSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102385Salvin Molt 9SALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102460Salvin West Periosteal ElevatorSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102859Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102866Salvin Bone File #12SALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102873Salvin Bone File #10SALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102880Salvin Bone File # 12CA Cross CutSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102897Salvin Bone File # 10CA Cross CutSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336104150Salvin Molt #2 Single End InstrumentSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336104167Salvin Molt 4 Single End InstrumentSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10