FDA.reportPublic FDA data

BUSCH®, BNA®

Primary DI
D8120104261
Brand
BUSCH®, BNA®
Company
BUSCH & CO. GmbH & Co. KG
Model
1RS 009 STEEL HP
Catalog number
010426
Device description
Stainless steel, round, rosehead
Published
2025-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8120104261PrimaryHIBCC0
D8120104260Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Steel dental bur, reusableA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315658617
Device count
2
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8120513291BUSCH®, BNA®5431 Dr. Korkut-Finish & Prep Set0513292026-06-01
D8120513301BUSCH®, BNA®5432 Dr. Korkut-Polishing Set0513302026-06-01
D8120102451BUSCH®, BNA®1 016 STEEL RA-L0102452025-12-15
D8120102531BUSCH®, BNA®1 021 STEEL RA-L0102532025-12-15
D8120102691BUSCH®, BNA®1 005 STEEL RA0102692025-12-15
D8120103251BUSCH®, BNA®1 027 STEEL RA0103252025-12-15
D8120103331BUSCH®, BNA®1 031 STEEL RA0103332025-12-15
D8120104211BUSCH®, BNA®1RS 005 STEEL HP0104212025-12-15
D8120104271BUSCH®, BNA®1RS 010 STEEL HP0104272025-12-15
D8120104281BUSCH®, BNA®1RS 012 STEEL HP0104282025-12-15
D8120104291BUSCH®, BNA®1RS 014 STEEL HP0104292025-12-15
D8120104301BUSCH®, BNA®1RS 016 STEEL HP0104302025-12-15
D8120104311BUSCH®, BNA®1RS 018 STEEL HP0104312025-12-15
D8120104321BUSCH®, BNA®1RS 021 STEEL HP0104322025-12-15
D8120104331BUSCH®, BNA®1RS 023 STEEL HP0104332025-12-15
D8120105491BUSCH®, BNA®2 006 STEEL RA0105492025-12-15
D8120105651BUSCH®, BNA®2 010 STEEL RA0105652025-12-15
D8120105731BUSCH®, BNA®2 014 STEEL RA0105732025-12-15
D8120117171BUSCH®, BNA®38 010 STEEL RA0117172025-12-15
D8120117211BUSCH®, BNA®38 012 STEEL RA0117212025-12-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04099797012033Depth stopALTATEC GmbHEJL2026-08-17
04099797012040Depth stopALTATEC GmbHEJL2026-08-17
04099797012057Depth stopALTATEC GmbHEJL2026-08-17
04099797012064Depth stopALTATEC GmbHEJL2026-08-17
04099797012071Depth stopALTATEC GmbHEJL2026-08-17
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04099797012415PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
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