FDA.reportPublic FDA data

Alpen Diamond Instruments

Primary DI
J006RS8508C018FG0
Brand
Alpen Diamond Instruments
Company
Coltène/Whaledent AG
Model
RS8508C018FG
Catalog number
RS8508C018FG
Published
2022-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
J006RS8508C018FG0PrimaryHIBCC0
J006500004590Unit 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

Contacts#

Phone, Email table
PhoneEmail
+41717575300info.ch@coltene.com

Regulatory Flags#

DUNS number
480017482
Device count
10
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
07640181476947BRILLIANT EverGlowUniv. Comp B-EA1 2025-07-08
07640181476954BRILLIANT EverGlowUniv. Comp B-EA22025-07-08
07640181476961BRILLIANT EverGlowUniv. Comp B-EA32025-07-08
07640181476985BRILLIANT EverGlowUniv. Comp B-EB12025-07-08
J00672800Etchant Gel728072802016-08-15
J00673730Etchant Gel737373732016-08-15
J00673740Etchant Gel737473742016-08-15
J00656300SwissTEC Etchant563056302016-08-15
J0065630L0SwissTEC Etchant5630 L5630 L2016-08-15
J00656310SwissTEC Etchant563156312016-08-15
J00644450PSI444544452016-08-15
J00644400PSI444044402016-08-15
07640181476879BRILLIANT Bulk Fill Flow600368242025-04-29
07640181476886BRILLIANT Bulk Fill Flow600332802025-04-29
J0006600332800BRILLIANT Bulk Fill Flow600332802024-09-22
J0006600368240BRILLIANT Bulk Fill Flow600368242024-09-22
J006600117570One Coat Bond60011757600117572016-08-15
J006600195380ONE COAT 7 UNIVERSAL60019538600195382016-08-15
J006600195390ONE COAT 7 UNIVERSAL60019539600195392016-08-15
J006600195400ONE COAT 7 UNIVERSAL60019540600195402016-08-15

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