FDA.reportPublic FDA data

JOTA

Primary DI
EJOT310205196002012
Brand
JOTA
Company
Jota AG
Model
38R.RAL.012
Device description
Steel
Published
2023-10-10
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
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EJOT310205196002012PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing brushA rotational device, typically composed of a metal shaft with bristles containing silicium carbide material, that is used for the quick grinding and polishing of dental composite materials and hard dental tissues to produce a high shine. It is held in a dental handpiece, which rotates the brush at high speeds [e.g., 5000 revolutions per minute (rpm)]. It is suitable for interproximal areas and occlusal surfaces. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480670983
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EJOT806313545724S16JOTASL846R.FGS.0162025-11-19
EJOT806314001704S14JOTASL801EF.FG.0142025-11-19
EJOT806314001714S23JOTASL801F.FG.0232025-11-19
EJOT806314001724S10JOTASL801.FG.0102025-11-19
EJOT806314001724S14JOTASL801.FG.0142025-11-19
EJOT806314001724S16JOTASL801.FG.0162025-11-19
EJOT806314001724S18JOTASL801.FG.0182025-11-19
EJOT806314001734S18JOTASL801G.FG.0182025-11-19
EJOT806314001734S23JOTASL801G.FG.0232025-11-19
EJOT806314012724S12JOTASL805.FG.0122025-11-19
EJOT806314012724S16JOTASL805.FG.0162025-11-19
EJOT806314012724S18JOTASL805.FG.0182025-11-19
EJOT806314012734S16JOTASL805G.FG.0162025-11-19
EJOT806314038724S32JOTASL811.FG.0322025-11-19
EJOT806314042724S26JOTASL815.FG.0262025-11-19
EJOT806314068724S42JOTASL909.FG.0422025-11-19
EJOT806314068734S35JOTASL909G.FG.0352025-11-19
EJOT806314068734S42JOTASL909G.FG.0422025-11-19
EJOT806314109724S10JOTASL836.FG.0102025-11-19
EJOT806314111724S12JOTASL837L.FG.0122025-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESUNC1623160165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2025-04-29
07630049901384C141 Allport bone cutterDiaswiss SAEJL2023-10-02
07630049901612DIA-ZDiaswiss SAEJL2023-10-02
07630049902077Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951051Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951075Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951532Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049951556FG Diacarb finishing bur HCDiaswiss SAEJL2023-10-02
07630049951921C141 Allport bone cutterDiaswiss SAEJL2023-10-02
07630049951983Carbide bur Diacarb RA HCDiaswiss SAEJL2023-10-02
07630049952003Carbide finishing bur Diacarb RADiaswiss SAEJL2023-10-02
07630049952041FG Diacarb carbide crown cutterDiaswiss SAEJL2023-10-02
07630049952065Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049952089FG Diacarb finishing burDiaswiss SAEJL2023-10-02
07630049952164FG Diacarb finishing burDiaswiss SAEJL2023-10-02
07630049952188FG Diacarb finishing burDiaswiss SAEJL2023-10-02
ESUNC283K3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-25
ESUNC33L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC33L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040275Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCTR323140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC463140145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07