FDA.reportPublic FDA data

BUSCH®, BNA®

Primary DI
D8120149281
Brand
BUSCH®, BNA®
Company
BUSCH & CO. GmbH & Co. KG
Model
312RS Mandrel RA
Catalog number
014928
Device description
Polisher, Soft Disc mandrel
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
EHJDISK, ABRASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8120149281PrimaryHIBCC0
D8120149280Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental mandrelA slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. 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
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
D8120104261BUSCH®, BNA®1RS 009 STEEL HP0104262025-12-15
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
D8120117291BUSCH®, BNA®38 016 STEEL RA0117292025-12-15

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Primary DI, Brand, Company table
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00348783012019Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
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