FDA.reportPublic FDA data

Alpen

Primary DI
D661600222061
Brand
Alpen
Company
COLTENE/WHALEDENT INC
Model
60022206
Device description
SHAPEGUARD ZIRCONIA PLUS STEP 2 140
Published
2019-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EJQWheel, Polishing Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D661600222061PrimaryHIBCC0
D661600222060Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

Regulatory Flags#

DUNS number
622185718
Device count
5
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D661XL848SC0161AlpenXL848SC0162019-02-12
D661R862C016FG1AlpenR862C016FG2019-02-11
D661R862EF010FG1AlpenR862EF010FG2019-02-11
D661R862EF012FG1AlpenR862EF012FG2019-02-11
D661R862F010FG1AlpenR862F010FG2019-02-11
D661R862F012FG1AlpenR862F012FG2019-02-11
D661R862F016FG1AlpenR862F016FG2019-02-11
D661R862SC014FG1AlpenR862SC014FG2019-02-11
D661R862UF010FG1AlpenR862UF010FG2019-02-11
D661R862UF012FG1AlpenR862UF012FG2019-02-12
D661R863C012FG1AlpenR863C012FG2019-02-12
D661R863EF012B1AlpenR863EF012B2019-02-11
D661R863EF012FG1AlpenR863EF012FG2019-02-12
D661R863EF016FG1AlpenR863EF016FG2019-02-12
D661R863F012FG1AlpenR863F012FG2019-02-11
D661R863F016FG1AlpenR863F016FG2019-02-11
D661R863SC016FG1AlpenR863SC016FG2019-02-11
D661R864F014FG1AlpenR864F014FG2019-02-11
D661R877C010FG1AlpenR877C010FG2019-02-12
D661R877C012FG1AlpenR877C012FG2019-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243641123KENDADent4You AGEJQ2025-09-17
07630243641130KENDADent4You AGEJQ2025-09-17
07630243641147KENDADent4You AGEJQ2025-09-17
07630243641154KENDADent4You AGEJQ2025-09-17
07630243641161KENDADent4You AGEJQ2025-09-17
07630243641178KENDADent4You AGEJQ2025-09-17
07630243641185KENDADent4You AGEJQ2025-09-17
07630243641192KENDADent4You AGEJQ2025-09-17
07630243641208KENDADent4You AGEJQ2025-09-17
07630243641215KENDADent4You AGEJQ2025-09-17
07630243641222KENDADent4You AGEJQ2025-09-17
07630243641239KENDADent4You AGEJQ2025-09-17
07630243641246KENDADent4You AGEJQ2025-09-17
07630243641253KENDADent4You AGEJQ2025-09-17
07630243641260KENDADent4You AGEJQ2025-09-17
07630243641277KENDADent4You AGEJQ2025-09-17
07630243641284KENDADent4You AGEJQ2025-09-17
07630243641291KENDADent4You AGEJQ2025-09-17
07630243641307KENDADent4You AGEJQ2025-09-17
07630243641314KENDADent4You AGEJQ2025-09-17
07630243641321KENDADent4You AGEJQ2025-09-17
07630243641338KENDADent4You AGEJQ2025-09-17
07630243641345KENDADent4You AGEJQ2025-09-17
07630243641352KENDADent4You AGEJQ2025-09-17
07630243641369KENDADent4You AGEJQ2025-09-17
07630243641376KENDADent4You AGEJQ2025-09-17
07630243641383KENDADent4You AGEJQ2025-09-17
07630243641390KENDADent4You AGEJQ2025-09-17
07630243641420KENDADent4You AGEJQ2025-09-17
07630243641437KENDADent4You AGEJQ2025-09-17