FDA.reportPublic FDA data

KENDA

Primary DI
07630243641420
Brand
KENDA
Company
Dent4You AG
Model
3050.006
Catalog number
3050.006
Device description
KENDA Nobilis & Unicus Polishers for Composite and Ceramic, Assortment, RA, 6pcs
Published
2025-09-17
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
07630243641420PrimaryGS10
07630243636068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630243641420076302436414207630243641420
07630243636068076302436360687630243636068

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480152811
Device count
6
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
07640397422189HYDRIM 112W G4+ Instrument WasherG4-W10001G4-W100012026-02-11
07640397422349HYDRIM 112W G4+ Instrument WasherG4-W10001-LG4-W10001-L2026-02-11
07640397422356HYDRIM 112W G4+ Instrument WasherG4-W10001-RG4-W10001-R2026-02-11
07640397421250HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01C61WD-D012025-07-22
07640397421267HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-LC61WD-D01-L2025-07-22
07640397421274HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-RC61WD-D01-R2025-07-22
07640397421281HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-LCSC61WD-D01-LCS2025-07-22
07640397421885HYDRIM C61W G4 Instrument WasherC61W-D01C61W-D012025-01-15
07640397421892HYDRIM C61W G4 Instrument WasherC61W-D01-LC61W-D01-L2025-01-15
07640397421908HYDRIM C61W G4 Instrument WasherC61W-D01-RC61W-D01-R2025-01-15
07640397421915HYDRIM L110W Instrument WasherL110W-D01-LL110W-D01-L2025-01-15
07640397421922HYDRIM L110W Instrument WasherL110W-D01-RL110W-D01-R2025-01-15
07640397421939HYDRIM L110W G4 Instrument WasherL110W-D01-G4L110W-D01-G42025-01-15
07640397421946HYDRIM L110W G4 Instrument WasherL110W-D01-G4-LL110W-D01-G4-L2025-01-15
07640397421953HYDRIM L110W G4 Instrument WasherL110W-D01-G4-RL110W-D01-G4-R2025-01-15
07640397421960HYDRIM L110W G4 Instrument WasherL110W-D01SH-G4L110W-D01SH-G42025-01-15
07630243601202ParaCore588658862026-07-07
07630243601219ParaCore588758872026-07-07
07630243601226ParaCore60011391600113912026-07-07
07630243601301ParaCore60011392600113922026-07-07

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
07630243641437KENDADent4You AGEJQ2025-09-17
07630243641444KENDADent4You AGEJQ2025-09-17