FDA.reportPublic FDA data

BUSCH®, BNA®

Primary DI
D8120321261
Brand
BUSCH®, BNA®
Company
BUSCH & CO. GmbH & Co. KG
Model
CD 37 016 COOL-DIA FG
Catalog number
032126
Device description
Diamond, cone rounded edge, COOL DIAMANT, medium grit
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
DZPINSTRUMENT, DIAMOND, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8120321261PrimaryHIBCC0
D8120321260Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, 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
6
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243660995Alpen DiamondsDent4You AGDZP2026-09-04
07630243661237Alpen DiamondsDent4You AGDZP2026-09-04
07630243662470Alpen DiamondsDent4You AGDZP2026-09-04
07630243662494Alpen DiamondsDent4You AGDZP2026-09-04
07630243662517Alpen DiamondsDent4You AGDZP2026-09-04
07630243662531Alpen DiamondsDent4You AGDZP2026-09-04
07630243662555Alpen DiamondsDent4You AGDZP2026-09-04
07630243662579Alpen DiamondsDent4You AGDZP2026-09-04
07630243662593Alpen DiamondsDent4You AGDZP2026-09-04
07630243662616Alpen DiamondsDent4You AGDZP2026-09-04
07630243662630Alpen DiamondsDent4You AGDZP2026-09-04
07630243662654Alpen DiamondsDent4You AGDZP2026-09-04
07630243662678Alpen DiamondsDent4You AGDZP2026-09-04
07630243662692Alpen DiamondsDent4You AGDZP2026-09-04
07630243662715Alpen DiamondsDent4You AGDZP2026-09-04
07630243662739Alpen DiamondsDent4You AGDZP2026-09-04
07630243662753Alpen DiamondsDent4You AGDZP2026-09-04
07630243662777Alpen DiamondsDent4You AGDZP2026-09-04
07630243662791Alpen DiamondsDent4You AGDZP2026-09-04
07630243662814Alpen DiamondsDent4You AGDZP2026-09-04
07630243662838Alpen DiamondsDent4You AGDZP2026-09-04
07630243662852Alpen DiamondsDent4You AGDZP2026-09-04
07630243662876Alpen DiamondsDent4You AGDZP2026-09-04
07630243662890Alpen DiamondsDent4You AGDZP2026-09-04
07630243662913Alpen DiamondsDent4You AGDZP2026-09-04
07630243662937Alpen DiamondsDent4You AGDZP2026-09-04
07630243662951Alpen DiamondsDent4You AGDZP2026-09-04
07630243662975Alpen DiamondsDent4You AGDZP2026-09-04
07630243662999Alpen DiamondsDent4You AGDZP2026-09-04
07630243663019Alpen DiamondsDent4You AGDZP2026-09-04