FDA.reportPublic FDA data

JOTA

Primary DI
EJOT500206001298027
Brand
JOTA
Company
Jota AG
Model
C141A.RAXL.027
Device description
Carbide
Published
2023-10-17
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
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EJOT500206001298027PrimaryHIBCC0

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
EJOT1410JOTA14102026-07-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887919581727DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581741DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581765DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
08800394921293Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921309Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921316Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921323Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921330Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921347Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921354Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921361Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921378Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921385Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921392Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921408Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921415Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921422Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921439Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921446Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921453Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921460Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921477Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08059224218007INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218014INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
06942686761223DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761230DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761247DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761254DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21