FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919949862
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5030085U0
Device description
APICAL VERIFIER ASST 25 MM 6P+
Published
2023-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EILGAUGE, DEPTH, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919949862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919949862008879199498628879199498620887919949862

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, reusableA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535019247Brasseler USA5031780U05031780U02026-03-24
08404535024906Brasseler USA5032029U05032029U02026-03-23
08404535024937Brasseler USA5032030U05032030U02026-03-23
08404535024968Brasseler USA5032031U05032031U02026-03-23
08404535025156LARGE BONE BLADESBR1-12100-50BR1-12100-502026-03-23
08404535024579Brasseler USAFL17CHP5032016U02026-03-17
08404535024609Brasseler USAFL17MHP5032017U02026-03-17
08404535024630Brasseler USAFL17FHP5032018U02026-03-17
08404535024661Brasseler USAFL17UF5032019U02026-03-17
08404535021769BrioPrep Sterile Diamonds5031856U05031856U02025-11-21
08404535021790BrioPrep Sterile Diamonds5031857U05031857U02025-11-21
08404535021820BrioPrep Sterile Diamonds5031858U05031858U02025-11-21
08404535021851BrioPrep Sterile Diamonds5031859U05031859U02025-11-21
08404535021882BrioPrep Sterile Diamonds5031860U05031860U02025-11-21
08404535021912BrioPrep Sterile Diamonds5031861U05031861U02025-11-21
08404535021943BrioPrep Sterile Diamonds5031862U05031862U02025-11-21
08404535021974BrioPrep Sterile Diamonds5031863U05031863U02025-11-21
08404535022001BrioPrep Sterile Diamonds5031864U05031864U02025-11-21
08404535022124BrioPrep Sterile Diamonds5031880U05031880U02025-11-21
08404535022155BrioPrep Sterile Diamonds5031881U05031881U02025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D9098000661ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
D9098000671ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
D9098000681ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
D909800081C1ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
00842092186626PreatPreat CorporationEIL2025-09-05
D9098000341ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980008114ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980013716ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980013918ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980014010ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
00194613114893MSI Precision Specialty InstrumentsMed Saver, Inc.EIL2025-08-01
E8961732150SCHWERTA. Schweickhardt GmbH & Co. KGEIL2025-04-07
EZPF2474408HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIL2025-03-07
00371347018318Advance Dental ProductsThe Atlanta Dental Supply CompanyEIL2025-01-02
00371347018356Advance Dental ProductsThe Atlanta Dental Supply CompanyEIL2025-01-02
00841336121584Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIL2024-12-11
00190730084682Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084811Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084828Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084835Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084842Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084859Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
08800016113303Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016113488Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121612Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121629Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121636Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121643Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121650Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121667Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08