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
00887919581727DENTFLEX FIBER POST5013918L05013918L02026-09-25
00887919581741DENTFLEX FIBER POST5013919L05013919L02026-09-25
00887919581765DENTFLEX FIBER POST5013920L05013920L02026-09-25
08404535030334Brasseler USA5032038U05032038U02026-09-25
08404535030365Brasseler USA5032039U05032039U02026-09-25
08404535030396Brasseler USA5032040U05032040U02026-09-25
08404535030426Brasseler USA5032041U05032041U02026-09-25
08404535030433Brasseler USA5032042U05032042U02026-09-25
08404535030464Brasseler USA5032043U05032043U02026-09-25
08404535030488Brasseler USA5032044U05032044U02026-09-25
08404535030518Brasseler USA5032045U05032045U02026-09-25
08404535030549Brasseler USA5032046U05032046U02026-09-25
08404535030570Brasseler USA5032047U05032047U02026-09-25
08404535030600Brasseler USA5032048U05032048U02026-09-25
08404535030631Brasseler USA5032049U05032049U02026-09-25
08404535030662Brasseler USA5032050U05032050U02026-09-25
00887919673866Brasseler USA5022561U05022561U02023-01-25
00887919676201Brasseler USA5022789U05022789U02023-01-25
00887919749981Brasseler USA5025306U05025306U02023-01-25
00887919752301Brasseler USA5025362U05025362U02023-01-25

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