FDA.reportPublic FDA data

JOTA

Primary DI
EJOT1410
Brand
JOTA
Company
Jota AG
Model
1410
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
EJOT1410PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
480670983
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00810194409387AiraAIRA, LLCEJL2026-08-25
00810194409431AiraAIRA, LLCEJL2026-08-25
00810194409448AiraAIRA, LLCEJL2026-08-25
00810194409462AiraAIRA, LLCEJL2026-08-25
00810194409486AiraAIRA, LLCEJL2026-08-25
00810194409523AiraAIRA, LLCEJL2026-08-25
00810194409547AiraAIRA, LLCEJL2026-08-25
00810194409554AiraAIRA, LLCEJL2026-08-25
00810194409585AiraAIRA, LLCEJL2026-08-25
00810194409592AiraAIRA, LLCEJL2026-08-25
00810194409608AiraAIRA, LLCEJL2026-08-25
00810194409622AiraAIRA, LLCEJL2026-08-25
00810194409646AiraAIRA, LLCEJL2026-08-25
00810194409776AiraAIRA, LLCEJL2026-08-25
00810194409837AiraAIRA, LLCEJL2026-08-25
00810194409912AiraAIRA, LLCEJL2026-08-25
00810194409943AiraAIRA, LLCEJL2026-08-25
00810194409950AiraAIRA, LLCEJL2026-08-25
00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
00810226100138AiraAIRA, LLCEJL2026-08-25
00810226100213AiraAIRA, LLCEJL2026-08-25
00810226100268AiraAIRA, LLCEJL2026-08-25
00810226100275AiraAIRA, LLCEJL2026-08-25
00810226100572AiraAIRA, LLCEJL2026-08-25
00810226100985AiraAIRA, LLCEJL2026-08-25
00810226101043AiraAIRA, LLCEJL2026-08-25
00810226101050AiraAIRA, LLCEJL2026-08-25
00810226101081AiraAIRA, LLCEJL2026-08-25